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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 22, 2026

Optima XR200amx, Mobile Digital-Ready Radiographic System

Full official product description

Optima XR200amx, Mobile Digital-Ready Radiographic System | Optima XR220amx, Mobile Digital-Ready Radiographic System | Optima XR240amx, Mobile Digital Radiographic System

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Optima XR200amx, Mobile Digital-Ready Radiographic System; Optima XR220amx, Mobile Digital-Ready Radiographic System; plus 1 additional official variants listed below.

Identifiers to compare

  • UDI 00840682115278
  • UDI 00840682115261
  • UDI 00840682122351
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Optima XR200amx, Mobile Digital-Ready Radiographic SystemUDI-DI: 00840682115278; System IDs: 419383DP3, 773792XR200, 856355OPT, FEB5201004 unitsZ-2726-2026
Optima XR220amx, Mobile Digital-Ready Radiographic SystemUDI-DI: 00840682115261; System IDs: 05249MOB02.OLD, 205820DP1, 228818XR220, 229276M1, 240566P1, 301295OPTIMA2, 303788SBOPT1, 314251P5, 352LEEDP1, 386FLGDPXR3, 417347DPORT1, 512SAMCSB, 516632OPTIMA2, 540981ODP7, 563264OPT, 601445DP1, 615338HDP01, 661949DP2, 713441OPCDX1, 717657OPT1, 718206OPT240A, 727848SB1, 732321DP1, 757736DP3, 813302OPT1, 828213DXP1, 828286OPT1, 843847220D, 850070941, 865545DP3, 915821OPT1, 941342OP221, 972566XR220E, 985447TM4, SA1208MM05, SB2201700085WK, XR1034798WK7, XR1037005WK438 unitsZ-2727-2026
Optima XR240amx, Mobile Digital Radiographic SystemUDI-DI: 00840682122351 and 00840682123686; System IDs: 252847PP249, 281MSL2402, 291OPTI1, 312CCHSUPER7, 318487OPTIMA1, 360744OPT2402, 501686OPTI1, 504826XR241, 519941XR240A, 540776ODP3, 541472M4, 602344240C, 706291BEE9, 713799XR240, 770836BEE2, 813872OPT11, 813872OPT9, 843724OPT1, 843847OPT240, 870239OPT2, 905522AMX240, 973625DIG4, DF2402001002WK, SA1013MM1324 unitsZ-2728-2026

2What is the risk?

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

GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.

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 Brazil, Canada, Korea, Mexico, Saudi Arabia, Spain, UK.

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

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.