O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000

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.

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 frequency of the issue impacts your ability to ensure the system can be in place for procedures, an alternate imaging system should be considered. 2. If your system displays a placard identifying this issue, the placard must remain attached to the system. Your Medtronic Field Service Engineer will remove the placard upon completion of service. 3. Use the enclosed Customer Confirmation Form to confirm receipt of this notification letter. Send the completed Customer Confirmation Form to Medtronic via email at [email protected]. 4. This notice needs to be passed on to those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records. Additional Information: If you have any questions related to this issue, please contact your Medtronic Field Service Engineer or Technical Services for help at 1-888-826-5603 (24 hours/ 7 days per week) or email at [email protected].