SIGNA Premier MAX patient table caster lock checks may have been missed
GE SIGNA Premier MAX MR systems are being recalled because planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed.
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: FDA Class II recall over a maintenance verification step that may have been skipped, with no defect found or clinical consequence stated in the source.
Plain-English summary
The GE SIGNA Premier MAX (China Only) Nuclear Magnetic Resonance Imaging System is being recalled. The source states a quantity of 0 units, and the action covers all system ID numbers on which GE HealthCare performed planned maintenance in the stated period.
According to GE HealthCare, for certain MR systems the planned maintenance steps to check the functionality of the caster locks on the MR patient table may not have been performed. The affected system list includes SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier and further models. The FDA classified the action as Class II. The source does not report any injury having occurred.
Distribution was worldwide. The systems are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected systems using the system ID numbers and follow the instructions issued by GE HealthCare.
The recalled product
- Product
- GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI system
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.
Part of a larger recall action
This product is one of 22 recalled by GE Medical Systems, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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