Health product recall

Optima Mr360

Last updated

Summary

Product
Optima Mr360
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 Mr360 - Main Unit

403541MR, 604985MR1, 450670MR2

5433265-1, 5312366 (M50002BB)

Signa Hde 1.5t Mri System - Main Unit

514747MRI, 604202MR, 514341MRI, 604520MR2

S7505KY

Signa Explorer

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

6433266-1

Signa Artist

More than 10 numbers, contact manufacturer.

SIGNA ARTIST

Signa Voyager

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

SIGNA VOYAGER

Issue

Potential for injury if the Mr system is incorrectly deinstalled.

Recall start date: Mar 10, 2022

Additional information

Details
Original published date: 2022-03-23
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 I
Identification number
RA-64013