GE MR systems planned caster lock maintenance verification gap
GE HealthCare is recalling certain MR imaging systems because maintenance steps to verify caster lock functionality on the 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: This Class II recall addresses a maintenance verification gap on medical imaging equipment with no reported injuries or illnesses. The hazard is theoretical, involving potential patient safety risk from unverified caster lock functionality, but with no evidence of actual equipment failure or patient harm.
Plain-English summary
GE HealthCare is recalling certain MR imaging systems because the planned maintenance steps to check the functionality of caster locks on the patient table may not have been performed. This maintenance is critical to ensure the patient table remains stable and secure during MRI procedures.
The recall affects 330 units of various GE MR system models distributed worldwide to medical facilities. The specific systems affected are those on which GE HealthCare performed planned maintenance since March 1, 2023. Affected models 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, and SIGNA PET/MR, among others.
The caster locks prevent the patient table from moving unexpectedly during imaging procedures. GE HealthCare identified that the verification steps for these safety mechanisms may have been omitted during recent maintenance visits.
Healthcare facilities using affected MR systems should contact GE HealthCare for instructions on verifying caster lock functionality and completing any outstanding maintenance verification procedures.
The recalled product
- Product
- GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Category
- Medical Device — MRI Equipment
- Hazard
- maintenance-verification-gap
- patient-table-safety
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: 00195278229519
- 00840682115872
- 00840682115971
- 00840682118187
- 00840682123129
- 00840682146999
- Not applicable
- Not available
- 2023
Distribution
Distribution scope not specified by the agency.
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