Health product recall

Signa, Discovery and Optima Products

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

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