Mobile X-Ray System Recalled for Unexpected Column Motion During Parking
GE Healthcare is recalling the AMX Navigate Mobile X-Ray System due to an unexpected column motion defect that occurs during parking operations. Three units distributed in the United States are affected.
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: This is an FDA Class II medical device recall involving a mechanical malfunction that could present a safety risk to operators during use, though no illnesses or injuries have been reported. The unexpected column motion during parking operations represents a risk-of-harm scenario for medical equipment in active use.
Plain-English summary
GE Healthcare, LLC, is recalling the AMX Navigate Mobile X-Ray System due to unexpected column motion that occurs when attempting to park the device. This mechanical issue affects three units that have been distributed in the United States.
The affected units are identified by product codes AMXNV2000001WK, AMXNV2000002WK, and DF2401600003WK.
Healthcare facilities and professionals who have received equipment with these model numbers should verify their serial codes and contact GE Healthcare for additional information and guidance regarding this recall.
The recalled product
- Product
- AMX Navigate Mobile X-Ray System
- Manufacturer
- GE Healthcare, LLC
- 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)
- AMXNV2000001WK
- AMXNV2000002WK
- DF2401600003WK
Distribution
Distribution scope not specified by the agency.
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