Health product recall

Signa Products

Last updated

Summary

Product
Signa 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

Signa Hde 1.5t Mri System - Main Unit

514747MRI, 604202MR, 514341MRI, 604520MR2

S7505KY

Signa Artist

More than 10 numbers, contact manufacturer.

SIGNA ARTIST

Signa Explorer

780964EXP, 604988MRI, 519824MR, 416431MR, 514765MRI, 604941MR1, 604822MRTS, 418691MR, 250782MR

6433266-1

Optima Mr360 - Main Unit

403541MR, 604985MR1, 450670MR2

5433265-1, 5312366 (M50002BB)

Signa Voyager

4964226MR81, 450688MR1, 780679MRV, 780699MRV, 780679AMSTMOBL, 306664MR1

SIGNA VOYAGER

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: 2022-01-20
Alert / recall type
Health product recall
Category
Health product - Medical device - Radiology
Companies
Ge Healthcare (Tianjin) Company Limited

No. 266 Jingsan Road, Tianjin

China, 300308

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63831