Recall MonitorHealth Products
Discovery™, Optima™ and SIGNA™ MR Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Radiology
Product: Discovery™, Optima™ and SIGNA™ MR Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Optima™ MR450w MRI System - Main Unit - 32ch | Not applicable. | M7004ZJ |
| SIGNA™ Premier | Not applicable. | SIGNA PREMIER |
| Discovery™ MR450 1.5t MR System - Main Unit | Not applicable. | DISCOVERY MR450 1.5T MR SYSTEM |
| Optima™ MR450w MRI System - Main Unit - Gem | Not applicable. | M7000YN |
| SIGNA™ PET/MR | Not applicable. | SIGNA PET/MR |
| SIGNA™ Architect | Not applicable. | SIGNA ARCHITECT |
| Discovery™ MR750 MR System - Main Unit | Not applicable. | DISCOVERY MR750 3.0T |
| Optima™ MR450w MRI System - Main Unit - 16ch | Not applicable. | OPTIMA MR450W 1.5T |
Issue
GE Healthcare has become aware that 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. Recall start date: June 30, 2025