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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jun 24, 2026

Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 3, 2026, 7:43 PM 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.

Medtronic O-arm O2 Imaging System. Model Number: BI70002000.

Identifiers to compare

  • Model BI70002000
  • Serial Numbers
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.Model Number: BI70002000. GTIN (Serial Numbers): 00643169639683 (C1640), 00643169651814 (C3815, C3816, C3817, C3818, C3891, C3898, C3899, C3900, C3901, C3902, C3903, C3905, C3990, C3997, C3998, C3999, C4001, C4002, C4003, C4004, C4059, C4060, C4061, C4062, C4063, C4064, C4065, C4066, C4067, C4068, C4116, C4117, C4118, C4119, C4120, C4121, C4122, C4123, C4130, C4201, C4202, C4203, C4356, C4357, C4360, C4361), 00763000132378 (C2096, C2187), 00763000355555 (C2768), 00763000481599 (C3895, C3996), 00763000496586 (C3794, C3896, C4023, C4031, C4032, C4043, C4088, C4092), 00763000496593 (C3887, C3889, C3978, C3988, C3991, C3994, C4041, C4109, C4110, C4111, C4161), 00763000496609 (C3802), 00763000496630 (C4035), 00763000496647 (C4012, C4126, C4129), 00763000496661 (C3824, C3987, C4071, C4072), 00763000496678 (C3879), 00763000496692 (C3799, C3823, C3897, C3979, C4027, C4037, C4044, C4125), 00763000496708 (C3825), 00763000496715 (C4074, C4128), 00763000496722 (C3812, C3822, C3828, C3881, C4034, C4036, C4038, C4039, C4160), 00763000616304 (C3795), 00763000616397 (C3800), 00763000616441 (C3811), 00763000616458 (C3783, C3784), 00763000616564 (C3316, C3735, C3777, C3778, C3779, C3780, C3781, C3786, C3787, C3790, C3791, C3792, C3793, C3796, C3797, C3798), 00763000709365 (C4307), 00763000709372 (C4221, C4284, C4294, C4301, C4354, C4370, C4399), 00763000709389 (C4166, C4295, C4402), 00763000709396 (C4394), 00763000709402 (C4149, C4150), 00763000709419 (C4395), 00763000709426 (C4115, C4248, C4304), 00763000709457 (C4293, C4298,C4403), 00763000709464 (C4368), 00763000709488 (C4204, C4205, C4302, C4363, C4366), 00763000709518 (C4148, C4167, C4222, C4223, C4224, C4225, C4285, C4292, C4303, C4309, C4362, C4369, C4374, C4375), 00763000709532 (C4206, C4208, C4209, C4236, C4245, C4283, C4286, C4287, C4288, C4289, C4290, C4308, C4310, C4372, C4373, C4377, C4378), 00763000709556 (C4390), 00763000709570 (C4249, C4250), 00763000709594 (C4396), 00763000709631 (C3883, C3884, C3885, C3907, C3908, C3909, C3910, C3911, C3912, C3913, C3914, C3915, C3916, C3918, C3919, C3920, C3921, C3922, C3923, C3924, C3925, C3926, C3927, C3928, C3929, C3930, C3931, C3932, C3933, C3934, C3935, C3936, C3937, C3938, C3939, C3940, C3941, C3942, C3943, C3944, C3945, C3946, C3947, C3948, C3949, C3950, C3951, C3953, C3954, C3955, C3956, C3957, C3958, C3959, C3960, C3961, C3962, C3963, C3964, C3965, C3966, C3967, C3968, C3969, C3970, C3971, C3972, C3973, C3974, C3975, C3976, C3977, C3982, C3983, C3984, C4014, C4015, C4016, C4017, C4018, C4019, C4020, C4021, C4022, C4028, C4045, C4046, C4047, C4048, C4049, C4050, C4051, C4052, C4053, C4075, C4076, C4077, C4078, C4079, C4080, C4081, C4082, C4083, C4084, C4085, C4086, C4087, C4089, C4090, C4093, C4094, C4095, C4096, C4097, C4098, C4100, C4101, C4102, C4103, C4104, C4105, C4106, C4107, C4108, C4131, C4132, C4133, C4134, C4135, C4136, C4137, C4138, C4139, C4140, C4141, C4142, C4143, C4144, C4145, C4146, C4151, C4152, C4153, C4154, C4155, C4156, C4157, C4158, C4162, C4163, C4168, C4169, C4170, C4171, C4172, C4173, C4174, C4175, C4176, C4177, C4178, C4179, C4180, C4181, C4182, C4183, C4184, C4185, C4186, C4187, C4188, C4190, C4191, C4193, C4194, C4195, C4196, C4197, C4198, C4199, C4200, C4210, C4211, C4212, C4213, C4214, C4215, C4217, C4218, C4219, C4220, C4226, C4227, C4228, C4229, C4230, C4231, C4232, C4233, C4234, C4235, C4237, C4238, C4239, C4240, C4241, C4242, C4243, C4244, C4246, C4247, C4251, C4252, C4253, C4254, C4256, C4257, C4258, C4259, C4260, C4261, C4263, C4264, C4265, C4266, C4267, C4268, C4269, C4270, C4271, C4272, C4273, C4274, C4278, C4279, C4281, C4311, C4312, C4313, C4314, C4315, C4316, C4318, C4319, C4320, C4321, C4322, C4323, C4324, C4325, C4326, C4328, C4329, C4330, C4331, C4332, C4333, C4334, C4335, C4336, C4337, C4339, C4340, C4341, C4342, C4343, C4344, C4345, C4346, C4347, C4348, C4349, C4350, C4351, C4382, C4383, C4384, C4385, C4386, C4388, C4405, C4406, C4407, C4414, C4415, C4416, C4418, C4421, C4422, C4280), 00763000709648 (C4282, C4300), 00763000709662 (C4306, C4353), 00763000709686 (C4352), 00763000709693 (C4299, C4397), 00763000745462 (C4040), 00763000745486 (C3863, C4069, C4070), 00763000863203 (C4033), 00763000863210 (C3789, C3801, C3804, C3805, C3806, C3807, C3808, C3809, C3878, C3985, C4005, C4006, C4007, C4008, C4009, C4010, C4011), 00763000863241 (C3833, C3890, C3892, C3894, C3980, C3995, C4013, C4029), 00763000863265 (C3826, C4164, C4165), 00763000863272 (C3813, C3814, C3820, C3821, C3827, C3888, C3904, C3906, C3992, C4024, C4026, C4054, C4055, C4056, C4057, C4073, C4112, C4113, C4124, C4147, C4159), 00763000863302 (C3829, C3830, C3831, C3832, C3835, C3837, C3838, C3839, C3840, C3841, C3842, C3843, C3844, C3845, C3848, C3849, C3850, C3851, C3852, C3853, C3854, C3855, C3856, C3857, C3858, C3859, C3860, C3861, C3862, C3864, C3865, C3866, C3867, C3868, C3869, C3870, C3871, C3872, C3873, C3874, C3875, C3876), 00763000871109 (C4127), 00763000871116 (C3989), 00763000871123 (C3986, C3993, C4114), 00763000871130 (C3834, C4058), 00763000967314 (C4389), 00763000967321 (C4296), 00763000987701 (C4364, C4365), 00763000987732 (C4216).589 unitsZ-2451-2026

2What is the risk?

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

Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

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 distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Libya, Malaysia, Mexico, Morocco, Nepal, Netherlands, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.

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.