GE Recalls MR Imaging Systems Due to Unverified Caster Locks
GE HealthCare is recalling certain MR imaging systems because planned maintenance steps to verify caster lock functionality may not have been performed. Worldwide distribution includes 760 units.
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 a Class II FDA device recall affecting a safety-critical component (caster locks on patient tables) where maintenance verification may not have been performed. While no injuries or illnesses have been reported, the failure to verify caster lock functionality represents a risk-of-harm situation meeting the High severity criterion.
Plain-English summary
GE HealthCare has recalled the GE Signa Artist and related magnetic resonance (MR) imaging systems. Affected models include 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, SIGNA Artist Evo, and regional variants. The recall affects 760 units distributed worldwide.
The recall concerns maintenance procedures for the MR patient table in these systems. GE HealthCare identified that the planned maintenance steps intended to verify the functionality of the caster locks may not have been performed for systems that received planned maintenance on or after March 1, 2023.
GE HealthCare is recalling these systems to ensure that the required maintenance verification steps are completed and that caster lock functionality is confirmed. No injuries or illnesses have been reported related to this issue.
The recalled product
- Product
- GE Signa Artist, Nuclear Magnetic Resonance Imaging System
- Manufacturer
- GE Medical Systems, LLC
- Hazard
- maintenance-gap
- equipment-malfunction
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: 00840682123129
- 00840682146104
- 00195278117021
- 00840682123457
- 00195278126443
- 00195278210036
- Not available
- and Not applicable
- 2023
Distribution
Distribution scope not specified by the agency.
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