Signa, Discovery and Optima Products
Brand(s)
Last updated
Summary
Product
Signa, Discovery and Optima Products
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Affected products
Affected Products | Lot or serial number | Model or catalog number |
---|---|---|
Discovery Mr750w 3.0t Magnetic Resonance Imaging System - Main Unit | 613737MR1, 506648MR4 | DISCOVERY MR750W 3.0T |
Signa Architect | 403777SIGNA3T, 905527MR1, 604582MR750, E416249MR2, 780699MR3T | SIGNA ARCHITECT |
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 |
Optima Mr450w Mri System - Main Unit - Gem | More than 10 numbers, contact manufacturer. | M7000YN |
Signa Pet/Mr | 604822MRP1 | SIGNA PET/MR |
Signa Pioneer | 403253MR1, 250598MR1 | SIGNA PIONEER |
Signa 1.5t Excite Hd - Magnet | 519663MRC, 416813MR3, 416369MR2, 418653MRI | SIGNA 1.5T EXCITE HD MR SYSTEM |
Signa Hdxt 3.0t Mr System - Main Unit | 604739MR, 416369MR3T, 604270MR3T | SIGNA HDXT 3.0T MR SYSTEM |
Signa Premier | 514934MR4 | SIGNA PREMIER |
1.5t Signa Horizon Lx Magnetic Resonance System | 819333MRI, 778432MOBMR, 519663MRC1, 819825MRI | M1000RA/RD/RF/RG |
Discovery Mr450 1.5t Mr System - Main Unit | 250727MR2 | DISCOVERY MR450 1.5T MR SYSTEM |
Optima Mr450w Mri System - Main Unit - 16ch | 905522MR2, 519685MR2, 416212MR450, 902893MR1, 450466MR1 | OPTIMA MR450W 1.5T |
Optima Mr450w Mri System - Main Unit - 32ch | 613938MR1, 780532MR1, 403670MR1 | M7004ZJ |
Issue
GE Healthcare (GEHC) MR systems could potentially have a cryogen ventilation system that does not meet the venting requirements. Failure to have proper venting could present a safety issue if the cryogen gas is vented into the MR room during a magnet quench, potentially depriving the room of oxygen.
Recall start date: Jan 4, 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 II
Identification number
RA-63832
Get notified
Receive notifications for new and updated recalls and alerts by category.