Class 2 Device Recall OArm O2 Imaging System

• Date Initiated by Firm: April 26, 2024
• Date Posted: June 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2026-2024
• Recall Event ID: 94566
• 510(K)Number: K151000
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000
• Code Information: GTIN: 00643169639683 00763000616441 00763000616465 00763000616526 00763000616533 00763000616564 00763000616571 Serial Numbers: C3578 C3421 C3606 C3645 C3641 C3589 C3604 C3537 C3551 C1595 C1437 C3469 C3635 C3626 C3389 C3647 C3407 C3713 C3607 C1629
• FEI Number: 3004785967
• Recalling Firm/ Manufacturer: Medtronic Navigation, Inc.-Littleton; 300 Foster St; Littleton MA 01460-2017
• For Additional Information Contact: Rita Greenberg ; 978-698-6000
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 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 neuro.quality@medtronic.com. 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 rs.navtechsupport@medtronic.com.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB