Z-2026-2024Class II

O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and...

Name: Z-2026-2024 O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and...
Creator: Medtronic Navigation, Inc.-Littleton
Published: 2024-04-26
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2024-04-26 / Open, Classified / root cause: design

FDA source

Medtronic Navigation, Inc.-Littleton began a recall of O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients. Product Number: BI70002000 on 2024-04-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2026-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-26
Posted: 2024-06-06
Recalling firm: Medtronic Navigation, Inc
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
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: design
FDA 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 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].
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2026-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2026-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-06

Product code OWB

K151000Class IIO-Arm O2 Imaging SystemMedtronic, Inc. / cleared 2015-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)