Health product recall

Discovery, Signa and Optima MR Systems

Last updated

Summary

Product
Discovery, Signa and Optima MR Systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Discovery Mr750 3.0t 902473MR2 514848MR1 905522MR3T 416595MR1 604875MR750 519685MR3T DISCOVERY MR750 3.0T
Discovery Mr450 1.5t Mr System 250727MR2 DISCOVERY MR450 1.5T MR SYSTEM
Discovery Mr750w 3.0t 613737MR1 DISCOVERY MR750W 3.0T
Signa Pet/Mr 604822MRP1 SIGNA PET/MR
Signa Pioneer 403253MR1 250598MR1 SIGNA PIONEER
Signa Architect 905527MR1 604582MR750 E416249MR2 780699MR3T 506648MR4 905684MR3T SIGNA ARCHITECT
Signa Hdxt 1.5t Mr System 514473MR1 506452MR 705522MR2 MAMRIHDXT 250374MRTS KWMRIHDXT SIGNA HDXT 1.5T MR SYSTEM
Signa Hdxt 3.0t Mr System - Main Unit 416369MR3T SIGNA HDXT 3.0T MR SYSTEM
Optima Mr450w Mri System - Main Unit - 16ch 902893MR1 450466MR1 OPTIMA MR450W 1.5T
Optima Mr450w Mri System - Main Unit - 32ch 613938MR1 403670MR1 M7004ZJ
Optima Mr450w Magnetic Resonance Imaging System More than 10 numbers, contact manufacturer. M7000YN
Signa Premier 514934MR4 SIGNA PREMIER

Issue

B1+RMS predicted value may exceed user prescribed limit in low SAR mode for certain MR systems.

Recall start date: June 14, 2024

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
Healthcare
Recall class
Type II
Identification number
RA-75803

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