Medtronic Navigation, Inc.-Boxborough: Medtronic O-arm O2 Imaging System recall

Recall details

FDA classification

Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.

Status

Ongoing

Codes, lots and dates

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).

Quantity

589 units

Distribution

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.

Recalling firm

Medtronic Navigation, Inc.-Boxborough, Boxborough, MA

Voluntary or mandated

Voluntary: Firm initiated

Recall started

2026-05-19