Discovery, Signa and Optima MR Systems

Brand(s)

Last updated

2024-07-10

Summary

Product

Discovery, Signa and Optima MR Systems

Issue

Medical devices - Performance issue

What to do

Contact the manufacturer if you require additional information.

Audience

Healthcare

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

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

Recall start date: June 14, 2024

Details

Original published date: 2024-07-10

Alert / recall type

Health product recall

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