GE SIGNA Voyager AIR MRI systems may have unverified caster locks
GE HealthCare is recalling SIGNA Voyager AIR MRI systems in China where planned maintenance checks on patient table caster locks may not have been performed. Faulty locks could allow the patient table to move unexpectedly during imaging.
What this means for you
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 a Class II medical device recall with no reported illnesses, injuries, or deaths. The hazard—potential caster lock failure allowing unintended table movement during MRI imaging—represents a risk-of-harm scenario where injury has not yet been reported, meeting the rubric criterion for a severity score of 3.
Plain-English summary
GE HealthCare has recalled SIGNA Voyager AIR MRI systems distributed in China due to a maintenance issue: planned maintenance steps to verify the functionality of the caster locks on the MR patient table may not have been performed.
The patient table caster locks are mechanisms that secure the table during MRI imaging. If these locks were not properly verified during maintenance, they may fail to function correctly, allowing the table to move unexpectedly during a scan.
The recall applies to all SIGNA Voyager AIR systems in China where GE HealthCare performed planned maintenance on or after March 1, 2023. The FDA recall identification number is Z-2311-2025.
The recalled product
- Product
- GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI Systems
- Hazard
- caster-lock-failure
- unintended-movement
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 (2)
- GTIN: unknown
- 2023
Distribution
Distribution scope not specified by the agency.
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