FDA recall, , Moderate risk
Medtronic O-Arm O2 Imaging System
The O-arm O2 Imaging System may show image artifacts due to a detector panel firmware anomaly.
Summary by Recall Canary from the FDA notice
What happened
Medtronic Navigation, Inc.-Boxborough, of Boxborough, Massachusetts, began a recall of the Medtronic O-arm O2 Imaging System, Model Number BI70002000, on May 19, 2026. The FDA added the recall to its Enforcement Report and classified it on June 15, 2026. The recall affects 589 units distributed nationwide and worldwide, including countries such as Canada, Germany, Japan, and the United Kingdom.
The agency stated the potential for image artifacts caused by an anomaly in the detector panel firmware.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Medtronic O-arm O2 Imaging System.
- Model
- BI70002000
- UDI-DI
- 00643169639683
- 00643169651814
- 00763000132378
- 00763000355555
- 00763000481599
- 00763000496586
- 00763000496593
- 00763000496609
- 00763000496630
- 00763000496647
- 00763000496661
- 00763000496678
- 00763000496692
- 00763000496708
- 00763000496715
- 00763000496722
- 00763000616304
- 00763000616397
- 00763000616441
- 00763000616458
- 00763000616564
- 00763000709365
- 00763000709372
- 00763000709389
- 00763000709396
- 00763000709402
- 00763000709419
- 00763000709426
- 00763000709457
- 00763000709464
- 00763000709488
- 00763000709518
- 00763000709532
- 00763000709556
- 00763000709570
- 00763000709594
- 00763000709631
- 00763000709648
- 00763000709662
- 00763000709686
- 00763000709693
- 00763000745462
- 00763000745486
- 00763000863203
- 00763000863210
- 00763000863241
- 00763000863265
- 00763000863272
- 00763000863302
- 00763000871109
- 00763000871116
- 00763000871123
- 00763000871130
- 00763000967314
- 00763000967321
- 00763000987701
- 00763000987732
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Guatemala, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Libya, Malaysia, Mexico, Morocco, Nepal, Netherlands, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
- Company
- Medtronic Navigation, Inc.-BoxboroughBoxborough, Massachusetts
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99041
- Recall number
- Z-2451-2026
- Quantity recalled
- 589 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
