Recall Z-2451-2026
Medtronic Navigation, Inc.-Boxborough · initiated May 19, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic O-arm O2 Imaging System. Model Number: BI70002000.
Codes / lots: 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…
Reason for recall
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
FDA-determined cause: Under Investigation by firm
Action taken
Medtronic notified consignees on about 05/19/2026 via "URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION" letter. Consignees were informed that affected systems may continue to be used prior to service by Medtronic to update the firmware. The issue is intermittent and may not present, however if it does it can be resolved by power cycling (rebooting) the system. A Medtronic Field Service Engineer will contact each facility to schedule time to update the firmware on each system to permanently resolve this issue. Consignees were instructed to complete and return the provided Customer Confirmation Form, provide the notification to all applicable personnel within the organization or to customers if product has been transferred, and to maintain a copy of the notice with their records.
Details
- Recall number
- Z-2451-2026
- Initiated
- May 19, 2026
- Posted by FDA
- June 15, 2026
- Product code
- OWB – Interventional Fluoroscopic X-Ray System
- 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…
- Recalling firm
- Medtronic Navigation, Inc.-Boxborough, Boxborough, MA