Health product recall

Optima Mr450w

Last updated

Summary

Product
Optima Mr450w
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 Mr450w Mri System - Main Unit - 16ch

905522MR2, 519685MR2, 416212MR450, 902893MR1, 450466MR1

OPTIMA MR450W 1.5T

Signa Architect

Not applicable, 905527MR1, 604582MR750, E416249MR2,780699MR3T

SIGNA ARCHITECT

Optima Mr450w Mri System - Main Unit - 32ch

613938MR1, 780532MR1, 403670MR1

M7004ZJ

Optima Mr450w Mri System - Main Unit - Gem

More than 10 numbers, contact manufacturer.

M7000YN

Signa Hdxt 3.0t Mr System - Main Unit

604739MR, 416369MR3T, 604270MR3T

SIGNA HDXT 3.0T MR SYSTEM

Discovery Mr750w 3.0t Magnetic Resonance Imaging System - Main Unit

613737MR1, 506648MR4

DISCOVERY MR750W 3.0T

Signa Pet/Mr

604822MRP1

SIGNA PET/MR

Signa Pioneer

403253MR1, 250598MR1

SIGNA PIONEER

1.5t Signa Horizon Lx Magnetic Resonance System

778432MOBMR, 819333MRI, 819825MRI, 519663MRC1

M1000RA/RD/RF/RG

Signa 1.5t Excite Hd - Magnet

519663MRC, 416813MR3, 416369MR2, 418653MRI

SIGNA 1.5T EXCITE HD MR SYSTEM

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

Discovery Mr450 1.5t Mr System - Main Unit

250727MR2

DISCOVERY MR450 1.5T MR SYSTEM

Signa Premier

514934MR4

SIGNA PREMIER

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 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 I
Identification number
RA-64011