GE MR Systems Patient Table Caster Lock Maintenance Recall
GE HealthCare is recalling certain MR imaging systems because planned maintenance steps to verify caster lock functionality on the patient table may not have been completed.
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 recall for a risk-of-harm medical device where no injuries or illnesses have been reported. The hazard is related to potentially unverified caster lock functionality, which could affect patient safety, but without any documented incidents.
Plain-English summary
GE HealthCare has issued a Class II recall for certain MR imaging systems because scheduled maintenance procedures to check the functionality of caster locks on the MR patient table may not have been performed.
The affected systems include SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR, and various China-only variants. The recall applies to all units that received planned maintenance since March 1, 2023.
Caster locks on the patient table are safety-critical equipment. If the required maintenance steps were not completed, lock functionality may not have been properly verified, creating a potential patient safety concern.
Affected healthcare facilities should contact GE HealthCare to verify whether the required maintenance was performed on their systems and obtain any necessary instructions for proper lock verification.
The recalled product
- Product
- GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- caster-lock-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: unknown
- 2023
Distribution
Distribution scope not specified by the agency.
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