Medtronic O-arm O2 Imaging System. Model Number: BI70002000. recall (Medtronic Navigation, Inc.-Boxborough)

Medical deviceClass IIOngoing

Summary: Medtronic Navigation, Inc.-Boxborough is recalling Medtronic O-arm O2 Imaging System. Model Number: BI70002000.. Reason: Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.

What is being recalled

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

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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. (states named: Georgia, Puerto Rico)

How to tell if yours is affected

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).

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Medtronic Navigation, Inc.-Boxborough · all medical device recalls · recalls from May 2026

Official FDA record