GE SIGNA PET/MR AIR Plus: Caster lock maintenance check may not have been performed
GE HealthCare recalled certain MR imaging systems because the planned maintenance steps to check caster lock functionality on the patient table may not have been performed. Affected systems include SIGNA PET/MR AIR Plus (China Only).
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 medical imaging device where the hazard (potential caster lock failure due to unverified maintenance) is theoretical with no reported illnesses or injuries. Per the rubric, this qualifies as Score 3: a risk-of-harm product where injury has not been reported.
Plain-English summary
GE HealthCare recalled certain MR imaging systems because the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
The affected systems include SIGNA PET/MR AIR Plus (China Only) and other MR models. This affects all systems where GE HealthCare performed planned maintenance since March 1, 2023.
The recalled product
- Product
- GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- maintenance-failure
- equipment-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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