Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Summary
The FDA issued a Class II for Medtronic O-arm O2 Imaging System. Model Number: BI70002000. by Medtronic Navigation, Inc.-Boxborough. Reason: Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware..
Details
Source
Device Recall
External ID
Z-2451-2026
Action Date
2026-06-24
Status
Ongoing
Category
device
Product Description
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Lot/Code Info: 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 Affected: 589 units
Reason for Recall
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-19
Company
Boxborough, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Medtronic Navigation, Inc.-Boxborough has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Navigation, Inc.-Boxborough) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Navigation, Inc.-Boxborough have FDA actions?
Medtronic Navigation, Inc.-Boxborough has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2451-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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