Medtronic O-arm Imaging System Recalled for Braking System Failure
Medtronic is recalling 463 O-arm Imaging Systems worldwide due to a potential failure of the braking system controlling vertical gantry movement.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a mechanical failure in a medical device that could lead to injury, but the source text does not report any actual injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Navigation, Inc. is recalling 463 units of the Medtronic O-arm Imaging System, a mobile image-intensified fluoroscopic x-ray system. The recall is due to a potential failure of the braking system that controls the movement of the imaging gantry in the vertical direction.
The affected units were distributed worldwide, including the United States and numerous international markets. The specific units affected are identified by serial numbers 101 through 564 and unit 580. Units with serial numbers 565 and higher are not affected by this recall.
Healthcare facilities and users should contact Medtronic Navigation, Inc. for instructions on how to address this issue. The source text does not specify a particular action for consumers, as this is a medical device used in clinical settings.
The recalled product
- Product
- Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
- Manufacturer
- Medtronic Navigation, Inc.
- Category
- Medical Device — Imaging System
- Affected units
- 463
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Product Catalog Numbers: 9732719
- 9732719R
- 9733346
- 9733346R
- BI-700-00027
- BI-700-00027R
- BI-700-00027-GER
- BI-700-00027-GERR
- BI-700-00027-100
- BI-700-00027-100R
- BI-700-00027-120
- BI-700-00027-120R
- BI-700-00027-230
Distribution
Distributed nationwide across the United States.
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