GE MRI Systems May Have Missed Planned Caster Lock Maintenance
GE HealthCare is recalling certain MRI systems where planned maintenance checks of patient table caster locks may not have been performed. Patients should contact GE or their healthcare facility about past procedures on affected systems.
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 an FDA Class II recall involving a risk-of-harm product—failure of caster locks on an MRI patient table could cause unexpected table movement and patient injury. Although no illnesses or injuries have been reported, the maintenance gap creates a documented safety risk requiring corrective action.
Plain-English summary
GE HealthCare has identified that planned maintenance procedures to check the functionality of caster locks on the patient table may not have been performed on certain MRI systems. This affects multiple GE SIGNA models and related systems.
If caster locks are not functioning properly due to missed maintenance checks, the patient table could potentially move unexpectedly during an MRI scan. This could pose a safety risk to patients undergoing imaging on affected systems.
GE HealthCare is working with healthcare facilities to ensure all required maintenance checks are performed. Patients who have had MRI procedures on affected systems should contact their healthcare provider or GE HealthCare with any concerns.
The recalled product
- Product
- GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- maintenance-failure
- equipment-malfunction
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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