Optima MR450w
Brand(s)
Last updated
Summary
Product
Optima MR450w
Issue
Medical devices - Increased risk or new adverse events
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected Products | Lot or serial number | Model or catalog number |
|---|---|---|
| Optima Mr450w Mri System - Main Unit - 16ch | 905522MR2, 519685MR2, 416212MR450, 902893MR1, 450466MR1 | OPTIMA MR450W 1.5T |
| Signa Architect | Not applicable, 905527MR1, 604582MR750, E416249MR2,780699MR3T | SIGNA ARCHITECT |
| Optima Mr450w Mri System - Main Unit - 32ch | 613938MR1, 780532MR1, 403670MR1 | M7004ZJ |
| Optima Mr450w Mri System - Main Unit - Gem | More than 10 numbers, contact manufacturer. | M7000YN |
| Signa Hdxt 3.0t Mr System - Main Unit | 604739MR, 416369MR3T, 604270MR3T | SIGNA HDXT 3.0T MR SYSTEM |
| Discovery Mr750w 3.0t Magnetic Resonance Imaging System - Main Unit | 613737MR1, 506648MR4 | DISCOVERY MR750W 3.0T |
| Signa Pet/Mr | 604822MRP1 | SIGNA PET/MR |
| Signa Pioneer | 403253MR1, 250598MR1 | SIGNA PIONEER |
| 1.5t Signa Horizon Lx Magnetic Resonance System | 778432MOBMR, 819333MRI, 819825MRI, 519663MRC1 | M1000RA/RD/RF/RG |
| Signa 1.5t Excite Hd - Magnet | 519663MRC, 416813MR3, 416369MR2, 418653MRI | SIGNA 1.5T EXCITE HD MR SYSTEM |
| Discovery Mr750 Mr System - Main Unit | More than 10 numbers, contact manufacturer. | DISCOVERY MR750 3.0T |
| Signa Hdxt 1.5t Mr System - Main Unit | More than 10 numbers, contact manufacturer. | 1.5T SIGNA HDXT MR SYSTEM |
| Discovery Mr450 1.5t Mr System - Main Unit | 250727MR2 | DISCOVERY MR450 1.5T MR SYSTEM |
| Signa Premier | 514934MR4 | SIGNA PREMIER |
Issue
Potential for injury if the MR system is incorrectly deinstalled.
Recall start date: Mar 10, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies
Ge Medical Systems LLC
3200 North Grandview Blvd, Waukesha, Wisconsin
United States, 53188
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type I
Identification number
RA-64011
Get notified
Receive emails about new and updated recall and safety alerts.