GE SIGNA MRI Patient Tables: Caster Lock Maintenance Checks May Be Incomplete
GE HealthCare recalls certain SIGNA MRI systems because maintenance procedures to verify caster lock functionality on patient tables may not have been performed. Affected units underwent planned maintenance since March 1, 2023.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA medical device recall with no reported illnesses or injuries. The issue involves incomplete maintenance verification for a patient-table component; since no actual harm has been reported and the issue is precautionary in nature, this qualifies as a Moderate severity recall.
Plain-English summary
GE HealthCare is recalling certain SIGNA MRI systems because planned maintenance procedures to verify caster lock functionality on patient tables may not have been performed. The recall affects multiple SIGNA model systems that underwent planned maintenance since March 1, 2023.
Caster locks secure the patient table during MR imaging procedures. If maintenance verification steps for these locks were not completed as intended, the locks' functionality may not be properly assured.
Customers with affected systems should contact GE HealthCare to verify that the required maintenance checks have been completed on their equipment.
The recalled product
- Product
- GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- maintenance-failure
- caster-lock-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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