GE SIGNA MRI Patient Table Caster Lock Maintenance Alert
GE HealthCare is recalling SIGNA MRI systems because maintenance checks on patient table caster locks may not have been completed on systems serviced since March 2023. Operators should verify their system's maintenance status.
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: FDA Class II recall with no reported illnesses or injuries. The hazard involves potential caster lock malfunction on critical medical equipment where injury has not yet been reported, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE HealthCare has issued a recall notification for multiple SIGNA MRI systems regarding incomplete maintenance verification. The planned maintenance steps to check the functionality of caster locks on the MR patient table may not have been completed for systems that underwent planned maintenance since March 1, 2023.
Caster locks are safety mechanisms on the patient table designed to prevent unintended movement. The recall notification recommends that facility operators verify that the caster lock maintenance verification has been completed on their systems.
This recall affects multiple SIGNA MRI models, including systems distributed in China and worldwide. Facility operators should contact GE HealthCare to confirm their system's maintenance status and ensure all required verification steps have been performed.
The recalled product
- Product
- GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI System
- Hazard
- caster-lock-failure
- equipment-instability
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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