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Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.

Full official product description

Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145. | Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163. | Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808 | Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162. | Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139. | Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296. | Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262. | Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808 | Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215, K213583, K223458, K251397, K251808. | Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178. | Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number (REF): 782115. 510(k) Numbers: K163116, K173079, K183063, K193215, K213583, K223458, K251397, K251808 | Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153. | Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278. | Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166. | Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137. | Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130. | Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model Number (REF): 782160. | Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113. | Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.

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Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.; Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.; plus 17 additional official variants listed below.

Identifiers to compare

  • Serial Numbers

19 official variants

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.1. Model Number (REF): 782145. UDI: (01)00884838108684(21)17385. Serial Numbers: 17385.1 unitZ-1966-2026
Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model Number (REF): 782144. 3. Model Number (REF): 782163.1. Model Number (REF): 782118. UDI: (01)00884838099746(21)85655. Serial Numbers: 85655. 2. Model Number (REF): 782144. UDI: (01)00884838108677(21)71087. Serial Numbers: 71087. 3. Model Number (REF): 782163. UDI: (01)00884838115743(21)42299. Serial Numbers: 42299.3 unitsZ-1968-2026
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers:...1. Model Number (REF): 781342. UDI: (01)00884838055339(21)71693, (01)00884838055339(21)71581, (01)00884838055339(21)71582, (01)00884838055339(21)71607, (01)00884838055339(21)85216, (01)00884838055339(21)71106, (01)00884838055339(21)71477, (01)00884838055339(21)71512, (01)00884838055339(21)71966, (01)00884838055339(21)71967, (01)00884838055339(21)85147, (01)00884838055339(21)85224, (01)00884838055339(21)85318, (01)00884838055339(21)71462, (01)00884838055339(21)71619, (01)00884838055339(21)85250, (01)00884838055339(21)71002, (01)00884838055339(21)71037, (01)00884838055339(21)71269, (01)00884838055339(21)71841, (01)00884838055339(21)71885, (01)00884838055339(21)71897, (01)00884838055339(21)85126, (01)00884838055339(21)85109, (01)00884838055339(21)71296, (01)00884838055339(21)71188, (01)00884838055339(21)71088, (01)00884838055339(21)71387, (01)00884838055339(21)71799, (01)00884838055339(21)71040, (01)00884838055339(21)71344, (01)00884838055339(21)71583, (01)00884838055339(21)71916, (01)00884838055339(21)71368, (01)00884838055339(21)71756, (01)00884838055339(21)71822, (01)00884838055339(21)71459, (01)00884838055339(21)71022, (01)00884838055339(21)71185, (01)00884838055339(21)71286, (01)00884838055339(21)71378, (01)00884838055339(21)71646, (01)00884838055339(21)71732, (01)00884838055339(21)71612, (01)00884838055339(21)71340, (01)00884838055339(21)71336. Serial Numbers: 71693, 71581, 71582, 71607, 85216, 71106, 71477, 71512, 71966, 71967, 85147, 85224, 85318, 71462, 71619, 85250, 71002, 71037, 71269, 71841, 71885, 71897, 85126, 85109, 71296, 71188, 71088, 71387, 71799, 71040, 71344, 71583, 71916, 71368, 71756, 71822, 71459, 71022, 71185, 71286, 71378, 71646, 71732, 71612, 71340, 71336. 2. Model Number (REF): 781377. UDI: (01)00884838009813(21)42305, (01)00884838009813(21)42097, (01)00884838009813(21)42364, (01)00884838009813(21)42136, (01)00884838009813(21)42237, (01)00884838009813(21)42455, (01)00884838009813(21)42087, (01)00884838009813(21)42401, (01)00884838009813(21)42321, (01)00884838009813(21)42001, (01)00884838009813(21)42036, (01)00884838009813(21)42053, (01)00884838009813(21)42126, (01)00884838009813(21)42400. Serial Numbers: 42305, 42097, 42364, 42136, 42237, 42455, 42087, 42401, 42321, 42001, 42036, 42053, 42126, 42400. 3. Model Number (REF): 782103. UDI: (01)00884838098299(21)85672, (01)00884838098299(21)85673, (01)00884838098299(21)85674, (01)00884838098299(21)85646. Serial Numbers: 85672, 85673, 85674, 85646.64 unitsZ-1958-2026
Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF): 782162.1. Model Number (REF): 782143. UDI: (01)00884838108660(21)42218, (01)00884838108660(21)42225. Serial Numbers: 42218, 42225. 2. Model Number (REF): 782162. UDI: (01)00884838115736(21)71403. Serial Numbers: 71403.3 unitsZ-1955-2026
Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782108. 3. Model Number (REF): 782139.1. Model Number (REF): 781359. UDI: (01)00884838090057(21)48218, (01)00884838090057(21)48233. Serial Numbers: 48218, 48233. 2. Model Number (REF): 782108. UDI: (01)00884838098343(21)48652, (01)00884838098343(21)48551, (01)00884838098343(21)48669. Serial Numbers: 48652, 48551, 48669. 3. Model Number (REF): 782139. UDI: (01)00884838108639(21)29076, (01)00884838108639(21)29079. Serial Numbers: 29076, 29079.7 unitsZ-1960-2026
Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.1. Model Number (REF): 781196. UDI: None. Serial Numbers: 21957. 2. Model Number (REF): 781296. UDI: (01)00884838004108(21)32039, (01)00884838004108(21)32095. Serial Numbers: 32039, 32095.3 unitsZ-1951-2026
Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.1. Model Number (REF): 781262. UDI: (01)00884838068445(21)77144. Serial Numbers: 77144.1 unitZ-1957-2026
Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Num...1. Model Number (REF): 781358. UDI: (01)00884838088115(21)45121, (01)00884838088115(21)45148, (01)00884838088115(21)45160, (01)00884838088115(21)45438, (01)00884838088115(21)45034, (01)00884838088115(21)45049, (01)00884838088115(21)45066, (01)00884838088115(21)45090, (01)00884838088115(21)45141, (01)00884838088115(21)45149, (01)00884838088115(21)45170, (01)00884838088115(21)45250, (01)00884838088115(21)45290, (01)00884838088115(21)45085, (01)00884838088115(21)45312, (01)00884838088115(21)45376, (01)00884838088115(21)45122, (01)00884838088115(21)45169, (01)00884838088115(21)45191, (01)00884838088115(21)45192, (01)00884838088115(21)45203, (01)00884838088115(21)45204, (01)00884838088115(21)45207, (01)00884838088115(21)45220, (01)00884838088115(21)45228, (01)00884838088115(21)45229, (01)00884838088115(21)45249, (01)00884838088115(21)45278, (01)00884838088115(21)45279, (01)00884838088115(21)45320, (01)00884838088115(21)45028, (01)00884838088115(21)45195, (01)00884838088115(21)45174, (01)00884838088115(21)45165, (01)00884838088115(21)45382, (01)00884838088115(21)45011, (01)00884838088115(21)45055, (01)00884838088115(21)45075, (01)00884838088115(21)45113, (01)00884838088115(21)45147, (01)00884838088115(21)45152, (01)00884838088115(21)45235, (01)00884838088115(21)45237, (01)00884838088115(21)45245, (01)00884838088115(21)45264, (01)00884838088115(21)45269, (01)00884838088115(21)45277, (01)00884838088115(21)45316, (01)00884838088115(21)45322, (01)00884838088115(21)45337, (01)00884838088115(21)45338, (01)00884838088115(21)45353, (01)00884838088115(21)45398, (01)00884838088115(21)45414, (01)00884838088115(21)45429, (01)00884838088115(21)45051. Serial Numbers: 45121, 45148, 45160, 45438, 45034, 45049, 45066, 45090, 45141, 45149, 45170, 45250, 45290, 45085, 45312, 45376, 45122, 45169, 45191, 45192, 45203, 45204, 45207, 45220, 45228, 45229, 45249, 45278, 45279, 45320, 45028, 45195, 45174, 45165, 45382, 45011, 45055, 45075, 45113, 45147, 45152, 45235, 45237, 45245, 45264, 45269, 45277, 45316, 45322, 45337, 45338, 45353, 45398, 45414, 45429, 45051. 2. Model Number (REF): 782107. UDI: (01)00884838098336(21)45590, (01)00884838098336(21)62158, (01)00884838098336(21)62180, (01)00884838098336(21)62044, (01)00884838098336(21)45567, (01)00884838098336(21)62031, (01)00884838098336(21)62166, (01)00884838098336(21)62184, (01)00884838098336(21)62190, (01)00884838098336(21)62240, (01)00884838098336(21)45519, (01)00884838098336(21)45533, (01)00884838098336(21)62024, (01)00884838098336(21)62047, (01)00884838098336(21)62048, (01)00884838098336(21)62051, (01)00884838098336(21)62052, (01)00884838098336(21)45554, (01)00884838098336(21)62145, (01)00884838098336(21)62146, (01)00884838098336(21)62148, (01)00884838098336(21)45500, (01)00884838098336(21)45501, (01)00884838098336(21)45510, (01)00884838098336(21)45511, (01)00884838098336(21)45514, (01)00884838098336(21)45516, (01)00884838098336(21)45518, (01)00884838098336(21)45589, (01)00884838098336(21)62017, (01)00884838098336(21)62039, (01)00884838098336(21)62073, (01)00884838098336(21)62081, (01)00884838098336(21)62088, (01)00884838098336(21)45521, (01)00884838098336(21)45600, (01)00884838098336(21)45563, (01)00884838098336(21)45570, (01)00884838098336(21)62153, (01)00884838098336(21)62181, (01)00884838098336(21)62182, (01)00884838098336(21)62183. Serial Numbers: 45590, 62158, 62180, 62044, 45567, 62031, 62166, 62184, 62190, 62240, 45519, 45533, 62024, 62047, 62048, 62051, 62052, 45554, 62145, 62146, 62148, 45500, 45501, 45510, 45511, 45514, 45516, 45518, 45589, 62017, 62039, 62073, 62081, 62088, 45521, 45600, 45563, 45570, 62153, 62181, 62182, 62183. 3. Model Number (REF): 782136. UDI: (01)00884838108608(21)28568, (01)00884838108608(21)28503, (01)00884838108608(21)28515, (01)00884838108608(21)28528, (01)00884838108608(21)28577. Serial Numbers: 28568, 28503, 28515, 28528, 28577.103 unitsZ-1963-2026
Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105. 510(k) Numbers: K173079, K183063, K193215,...1. Model Number (REF): 781271. UDI: (01)00884838068452(21)78017, (01)00884838068452(21)78013, (01)00884838068452(21)78014, (01)00884838068452(21)78034, (01)00884838068452(21)78058, (01)00884838068452(21)78073, (01)00884838068452(21)78075, (01)00884838068452(21)78092, (01)00884838068452(21)78112, (01)00884838068452(21)78123, (01)00884838068452(21)78201, (01)00884838068452(21)78202, (01)00884838068452(21)78215, (01)00884838068452(21)78217, (01)00884838068452(21)78239, (01)00884838068452(21)78247, (01)00884838068452(21)78260,(01)00884838068452(21)78286, (01)00884838068452(21)78287, (01)00884838068452(21)78026. Serial Numbers: 78017, 78013, 78014, 78034, 78058, 78073, 78075, 78092, 78112, 78123, 78201, 78202, 78215, 78217, 78239, 78247, 78260, 78286, 78287, 78026. 2. Model Number (REF): 782105. UDI: (01)00884838098312(21)78532, (01)00884838098312(21)78576. Serial Numbers: 78532, 78576.22 unitsZ-1959-2026
Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.1. Model Number (REF): 781178. UDI: None. Serial Numbers: 20088.1 unitZ-1952-2026
Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. 3. Model Number (REF): 781396. 4. Model Number...1. Model Number (REF): 781315. UDI: (01)00884838099715(21)61067, (01)00884838099715(21)61058, (01)00884838099715(21)61056. Serial Numbers: 61067 61058, 61056. 2. Model Number (REF): 781341. UDI: (01)00884838055322(21)70229, (01)00884838055322(21)84667, (01)00884838055322(21)70311, (01)00884838055322(21)70668, (01)00884838055322(21)70845, (01)00884838055322(21)70851, (01)00884838055322(21)87151, (01)00884838055322(21)87112, (01)00884838055322(21)84322, (01)00884838055322(21)84323, (01)00884838055322(21)84228, (01)00884838055322(21)84789, (01)00884838055322(21)84261, (01)00884838055322(21)84500, (01)00884838055322(21)84556, (01)00884838055322(21)87187, (01)00884838055322(21)84840, (01)00884838055322(21)70685, (01)00884838055322(21)84661, (01)00884838055322(21)70787, (01)00884838055322(21)70063, (01)00884838055322(21)70621, (01)00884838055322(21)70743, (01)00884838055322(21)70911, (01)00884838055322(21)84049, (01)00884838055322(21)84088, (01)00884838055322(21)84147, (01)00884838055322(21)84254, (01)00884838055322(21)84283, (01)00884838055322(21)84403, (01)00884838055322(21)84433, (01)00884838055322(21)84460, (01)00884838055322(21)84462, (01)00884838055322(21)84467, (01)00884838055322(21)84475, (01)00884838055322(21)84734, (01)00884838055322(21)84538. Serial Numbers: 70229, 84667, 70311, 70668, 70845, 70851, 87151, 87112, 84322, 84323, 84228, 84789, 84261, 84500, 84556, 87187, 84840, 70685, 84661, 70787, 70063, 70621, 70743, 70911, 84049, 84088, 84147, 84254, 84283, 84403, 84433, 84460, 84462, 84467, 84475, 84498, 84538. 3. Model Number (REF): 781396. UDI: (01)00884838009820(21)41175, (01)00884838009820(21)41108, (01)00884838009820(21)41395, (01)00884838009820(21)41037, (01)00884838009820(21)41066, (01)00884838009820(21)41098, (01)00884838009820(21)41194, (01)00884838009820(21)41208, (01)00884838009820(21)41354, (01)00884838009820(21)41356, (01)00884838009820(21)41370, (01)00884838009820(21)41552. Serial Numbers: 41175, 41108, 41395, 41037, 41066, 41098, 41194, 41208, 41354, 41356, 41370, 41552. 4. Model Number (REF): 782115. UDI: (01)00884838099043(21)61214, (01)00884838099043(21)61221. Serial Numbers: 61214, 61221.54 unitsZ-1956-2026
Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.1. Model Number (REF): 782120. UDI: (01)00884838104112(21)65019, (01)00884838104112(21)65004, (01)00884838104112(21)65028, (01)00884838104112(21)65031, (01)00884838104112(21)65039, (01)00884838104112(21)65056, (01)00884838104112(21)65066, (01)00884838104112(21)65065, (01)00884838104112(21)65038, (01)00884838104112(21)65005, (01)00884838104112(21)65043, (01)00884838104112(21)65049, (01)00884838104112(21)65051, (01)00884838104112(21)65060. Serial Numbers: 65019, 65004, 65028, 65031, 65039, 65056, 65066, 65065, 65038, 65005, 65043, 65049, 65051, 65060. 2. Model Number (REF): 782153. UDI: (01)00884838112858(21)68034, (01)00884838112858(21)68042, (01)00884838112858(21)68014, (01)00884838112858(21)68001, (01)00884838112858(21)68007, (01)00884838112858(21)68008, (01)00884838112858(21)68017, (01)00884838112858(21)68025, (01)00884838112858(21)68037, (01)00884838112858(21)68041, (01)00884838112858(21)68019. Serial Numbers: 68034, 68042, 68014, 68001, 68007, 68008, 68017, 68025, 68037, 68041, 68019.25 untisZ-1964-2026
Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.1. Model Number (REF): 781278. UDI: (01)00884838004139(21)38103. Serial Numbers: 38103.1 unitZ-1953-2026
Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 782148. 3. Model Number (REF): 782166.1. Model Number (REF): 782116. UDI: (01)00884838099722(21)41527, (01)00884838099722(21)70949, (01)00884838099722(21)84741. Serial Numbers: 41527, 70949, 84741. 2. Model Number (REF): 782148. UDI: (01)00884838108714(21)84560, (01)00884838108714(21)41277, (01)00884838108714(21)70769, (01)00884838108714(21)70983. Serial Numbers: 84560, 41277, 70769, 70983. 3. Model Number (REF): 782166. UDI: (01)00884838115774(21)70042. Serial Numbers: 70042.8 unitsZ-1954-2026
Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 782106. 3. Model Number (REF): 782137.1. Model Number (REF): 781357. UDI: (01)00884838088108(21)46002. Serial Numbers: 46002. 2. Model Number (REF): 782106. UDI: (01)00884838098329(21)46243, (01)00884838098329(21)46292, (01)00884838098329(21)46317. Serial Numbers: 46243, 46292, 46317. 3. Model Number (REF): 782137. UDI: (01)00884838108615(21)64034, (01)00884838108615(21)64045. Serial Numbers: 64034, 64045.6 unitsZ-1962-2026
Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.1. Model Number (REF): 782130. UDI: (01)00884838104402(21)45052, (01)00884838104402(21)42030, (01)00884838104402(21)42151, (01)00884838104402(21)71279, (01)00884838104402(21)71565, (01)00884838104402(21)42104, (01)00884838104402(21)42163, (01)00884838104402(21)42376, (01)00884838104402(21)45179, (01)00884838104402(21)45236, (01)00884838104402(21)45263, (01)00884838104402(21)71532, (01)00884838104402(21)85394, (01)00884838104402(21)85643, (01)00884838104402(21)85644. Serial Numbers: 45052, 42030, 42151, 71279, 71565, 42104, 42163, 42376, 45179, 45236, 45263, 71532, 85394, 85643, 85644.15 unitsZ-1969-2026
Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782109. 3. Model Number (REF): 782138. 4. Model...1. Model Number (REF): 781356. UDI: (01)00884838090040(21)47056, (01)00884838090040(21)47272, (01)00884838090040(21)47189, (01)00884838090040(21)47310, (01)00884838090040(21)47006, (01)00884838090040(21)47029, (01)00884838090040(21)47044, (01)00884838090040(21)47068, (01)00884838090040(21)47196, (01)00884838090040(21)47206, (01)00884838090040(21)47208, (01)00884838090040(21)47237, (01)00884838090040(21)47260, (01)00884838090040(21)47289, (01)00884838090040(21)47291, (01)00884838090040(21)47294, (01)00884838090040(21)47303, (01)00884838090040(21)47305, (01)00884838090040(21)47322, (01)00884838090040(21)47325, (01)00884838090040(21)47330, (01)00884838090040(21)47339, (01)00884838090040(21)47380, (01)00884838090040(21)47387. Serial Numbers: 47056, 47272, 47189, 47310, 47006, 47029, 47044, 47068, 47196, 47206, 47208, 47237, 47260, 47289, 47291, 47294, 47303, 47305, 47322, 47325, 47330, 47339, 47380, 47387. 2. Model Number (REF): 782109. UDI: (01)00884838098350(21)47869, (01)00884838098350(21)47565, (01)00884838098350(21)47644, (01)00884838098350(21)47881, (01)00884838098350(21)47509, (01)00884838098350(21)47919, (01)00884838098350(21)47634, (01)00884838098350(21)47681, (01)00884838098350(21)47706, (01)00884838098350(21)47907, (01)00884838098350(21)47867, (01)00884838098350(21)47550, (01)00884838098350(21)47804, (01)00884838098350(21)47549, (01)00884838098350(21)47635, (01)00884838098350(21)47788, (01)00884838098350(21)47617, (01)00884838098350(21)47566, (01)00884838098350(21)47597, (01)00884838098350(21)47892, (01)00884838098350(21)47893, (01)00884838098350(21)47894, (01)00884838098350(21)47534, (01)00884838098350(21)47538, (01)00884838098350(21)47554, (01)00884838098350(21)47590, (01)00884838098350(21)47642, (01)00884838098350(21)47659, (01)00884838098350(21)47726, (01)00884838098350(21)47760, (01)00884838098350(21)47761, (01)00884838098350(21)47767, (01)00884838098350(21)47771, (01)00884838098350(21)47789, (01)00884838098350(21)47799, (01)00884838098350(21)47814, (01)00884838098350(21)47835, (01)00884838098350(21)47849, (01)00884838098350(21)47862, (01)00884838098350(21)47888, (01)00884838098350(21)47929, (01)00884838098350(21)47931, (01)00884838098350(21)47950, (01)00884838098350(21)47962. Serial Numbers: 47869, 47565, 47644, 47881, 47509, 47919, 47634, 47681, 47706, 47907, 47867, 47550, 47804, 47549, 47635, 47788, 47617, 47566, 47597, 47892, 47893, 47894, 47534, 47538, 47554, 47590, 47642, 47659, 47726, 47760, 47761, 47767, 47771, 47789, 47799, 47814, 47835, 47849, 47862, 47888, 47929, 47931, 47950, 47962. 3. Model Number (REF): 782138. UDI: (01)00884838108622(21)49004, (01)00884838108622(21)49251, (01)00884838108622(21)49045, (01)00884838108622(21)49058, (01)00884838108622(21)49129, (01)00884838108622(21)49153, (01)00884838108622(21)49165, (01)00884838108622(21)49161, (01)00884838108622(21)49205, (01)00884838108622(21)49228, (01)00884838108622(21)49206, (01)00884838108622(21)49057, (01)00884838108622(21)49100, (01)00884838108622(21)49172, (01)00884838108622(21)49210, (01)00884838108622(21)49215, (01)00884838108622(21)49231. Serial Numbers: 49004, 49251, 49045, 49058, 49129, 49153, 49165, 49161, 49205, 49228, 49206, 49057, 49100, 49172, 49210, 49215, 49231. 4. Model Number (REF): 782160. UDI: (01)00884838115712(21)92039. Serial Numbers: 92039.86 unitsZ-1961-2026
Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. Model Number (REF): 782113.1. Model Number (REF): 781270. UDI: (01)00884838095083(21)38109, (01)00884838095083(21)17386, (01)00884838095083(21)38356, (01)00884838095083(21)34211, (01)00884838095083(21)38113, (01)00884838095083(21)17356, (01)00884838095083(21)38111, (01)00884838095083(21)74011, (01)00884838095083(21)24058, (01)00884838095083(21)24066, (01)00884838095083(21)34223. Serial Numbers: 38109, 17386, 38356, 34211, 38113, 17356, 38111, 74011, 24058, 24066, 34223. 2. Model Number (REF): 782113. UDI: (01)00884838098909(21)38066, (01)00884838098909(21)38117, (01)00884838098909(21)17384. Serial Numbers: 38066, 38117, 17384.14 unitsZ-1967-2026
Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model Number (REF): 782112.1. Model Number (REF): 781260. UDI: (01)00884838095076(21)21554, (01)00884838095076(21)13018, (01)00884838095076(21)12033. Serial Numbers: 21554, 13018, 12033. 2. Model Number (REF): 782112. UDI: (01)00884838098886(21)30143, (01)00884838098886(21)22051, (01)00884838098886(21)32156. Serial Numbers: 30143, 22051, 32156.6 unitsZ-1965-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.
  • : affectedSummary changed in the official record.