Recall Z-2026-2024 ยท OWB Interventional Fluoroscopic X-Ray System
Medtronic Navigation, Inc.-Littleton
O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
| Date | Jun 6, 2024 (initiated Apr 26, 2024) |
| Status | Open, Classified |
| Reason | Potential for an electrical component of the O-arm" O2 Imaging System to intermittently shut off,failure can cause the potential for surgical delay, additional imaging, cancellation and rescheduling of surgery, or completion of surgery without the benefit of image guidance. |
| Root cause | Device Design |
| Action | Medtronic issued Urgent Medical Device Correction Letter on 4/26/24 to US end-users hand delivered via Field Service representative. OUS communications were initiated with affected consignees on April 17, 2024. Letter states reason for recall, health risk and action to take: A Medtronic Field Service Engineer will contact your facility to schedule time to service your system within 90 days. Required Actions: 1. If your system is actively in use, you may continue to use it pending service by Medtronic. If your system exhibits the issue, it will automatically reset after beeping. If the frequen |
| Quantity | 20 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, MN, PR, TX, WI and the countries of Bangladesh, Canada, Costa Rica, India, Mexico, Panama, Philippines. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151000 | O-Arm O2 Imaging System Medtronic, Inc., Aug 6, 2015 |