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O-ARM recallZ-2026-2024 · Medtronic Navigation, Inc.-Littleton · initiated Apr 26, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Navigation, Inc.-Littleton or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Device Design

What the company is doing

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].

Recall details

Recall number
Z-2026-2024
Status
Open, Classified
Initiated by the company
Apr 26, 2024
Posted by the FDA
Jun 6, 2024
Recalling firm
Medtronic Navigation, Inc.-Littleton
Quantity
20 units
Product code
OWB
FDA submissions
K151000
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.

Product description

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 (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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