GE HealthCare MRI Systems Caster Lock Maintenance Verification Recall
GE HealthCare recalled certain MRI systems after discovering that planned maintenance checks to verify caster lock functionality on patient tables may not have been performed on some units.
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 involving potential equipment malfunction (unverified caster locks on patient tables) that presents a risk of harm. No reported illnesses or injuries are documented, making this a risk-of-harm scenario without reported injury, which qualifies as a 3 (High) per the rubric.
Plain-English summary
GE HealthCare issued a recall for certain MRI systems after discovering that the planned maintenance steps to verify caster lock functionality on the patient table may not have been performed on some systems.
The recall affects multiple SIGNA models and other GE magnetic resonance imaging systems. Facilities with affected systems should verify that the maintenance procedures for caster lock verification have been completed and contact GE HealthCare if needed.
The recalled product
- Product
- GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- equipment-malfunction
- maintenance-failure
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: Not available
- 2023
Distribution
Distribution scope not specified by the agency.
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