MR Imaging System Caster Lock Maintenance May Not Have Been Performed
GE HealthCare recalls certain MR imaging systems where planned maintenance checks on patient table caster locks may not have been performed. The recall affects systems that received maintenance since March 1, 2023.
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: FDA Class II medical device recall affecting a critical safety feature (patient table locks) with no reported injuries or hospitalizations. This qualifies as a risk-of-harm product where injury has not yet been reported, matching the Score 3 criterion per the rubric.
Plain-English summary
GE HealthCare has identified a potential issue with certain MR (magnetic resonance) imaging systems distributed worldwide, including models such as SIGNA Artist Evo, SIGNA Voyager, Discovery MR450, Optima MR450w, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750, and SIGNA Hero. Approximately 138 units have been affected.
The issue affects systems that underwent planned maintenance since March 1, 2023. During these maintenance procedures, the specific steps to check the functionality of the caster locks on the patient table may not have been performed. Caster locks are safety mechanisms that secure the imaging table during patient procedures.
Healthcare facilities with affected systems should contact GE HealthCare to ensure that the caster lock functionality has been properly verified and confirmed on their equipment.
The recalled product
- Product
- GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- maintenance-omitted
- patient-fall-risk
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 00195278481382
- 00840682118118
- 00840682123129
- 00840682147095
- Not Applicable
- GTIN Not Available
- 2023
Distribution
Distribution scope not specified by the agency.
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