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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