Medtronic 0-arm Imaging System Recalled for Navigational Accuracy Issues
Medtronic is recalling three 0-arm Imaging Systems because software version 3.1.1 does not meet navigational accuracy standards.
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 is classified as FDA Class II, and the hazard involves a medical device failing to meet navigational accuracy standards, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Medtronic Navigation, Inc. is recalling three units of the 0-arm Imaging System, a mobile x-ray system designed for 2D fluoroscopic and 3D imaging. The recall involves specific catalog numbers (BI-700-00027-120R and BI-700-00027-120) and serial numbers 125, 156, and 234R. The affected units are equipped with software version 3.1.1.
The recall is being conducted because the software version 3.1.1 does not meet navigational accuracy requirements. The agency has classified this as a Class II recall.
The affected units were distributed nationwide, including in the states of Colorado, Indiana, and Minnesota. Users of these devices should contact Medtronic Navigation, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: BI-700-00027-120R and BI-700-00027-120. The 0-arm¿ Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging.
- Manufacturer
- Medtronic Navigation, Inc.
- Category
- Medical Device — Imaging System
- Hazard
- Affected units
- 3
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 (3)
- Serial Numbers: 125
- 156
- 234R.
Distribution
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