Medtronic 0-arm Imaging mobile x-ray system recall for battery damage risk
Medtronic is recalling 0-arm Imaging mobile x-ray systems because replacement batteries may be damaged during shipment, creating a risk of failure.
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 medical device with a risk of failure due to component damage, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Navigation, Inc. is recalling the Medtronic 0-arm Imaging mobile x-ray system, specifically model numbers B1-700-00027 and B1-700-00028. The recall involves 581 units distributed nationwide in the United States.
The recall was initiated because it was discovered that replacement x-ray generator and system motion batteries could become damaged during shipment. This damage results in an unacceptable risk of failure for the equipment.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this recall.
The recalled product
- Product
- Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Hazard
- Affected units
- 581
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 (1)
- Model No. BI-700-00027 and BT-700-00028
Distribution
Distributed nationwide across the United States.
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