Discovery MR750w patient table caster lock checks may have been missed
GE Discovery MR750w 3.0T 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. 519 units affected.
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 Discovery MR750w 3.0T Nuclear Magnetic Resonance Imaging System is being recalled across the GTINs listed in the recall notice. The action covers 519 units.
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, SIGNA UHP, Discovery MR750 3.0T, Discovery MR750w 3.0T, SIGNA Hero, SIGNA PET/MR 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 GTINs above and follow the instructions issued by GE HealthCare.
The recalled product
- Product
- GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI system
- Affected units
- 519
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 (9)
- GTIN: 00195278023643
- 00840682102704
- 00840682102728
- 00840682103787
- 00840682103817
- 00840682123440
- Not applicable
- Not Available
- 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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