GE Medical MRI Systems Caster Lock Maintenance Check Recall
GE HealthCare is recalling certain MRI systems because planned maintenance checks on caster lock functionality may not have been performed on some units. Approximately 280 systems are affected, with worldwide distribution.
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 medical device recall for a maintenance verification issue affecting safety locks. The rubric establishes that risk-of-harm products without reported injuries or illnesses score as High (3). No deaths, hospitalizations, or illnesses are reported in the source; the hazard is unchecked caster lock functionality, which presents potential risk during imaging procedures.
Plain-English summary
GE Medical Systems, LLC is recalling certain magnetic resonance imaging systems distributed worldwide. The planned maintenance procedures to verify that caster locks on the MR patient table function properly may not have been performed on certain units.
Approximately 280 units are affected, including various models from the Signa, Discovery, Optima, and other GE MRI product lines. The affected systems are those on which GE HealthCare performed planned maintenance on or after March 1, 2023.
Users of affected systems should contact GE HealthCare to confirm whether the required maintenance verification has been completed on their unit.
The recalled product
- Product
- GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- equipment-malfunction
- maintenance-failure
- caster-lock-defect
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 (7)
- GTIN: 00840682108607
- 00195278124609
- 00195278248923
- 00840682118118
- Not applicable
- Not available
- 2023
Distribution
Distribution scope not specified by the agency.
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