The Recall Desk
HighFDA (Devices)·Z-1305-2015·Announced 2015-04-01

GE Healthcare Recalls MRI Systems Due to Software Maintenance Issues

GE Healthcare is recalling 9,369 MRI systems worldwide because software versions were not maintained properly at some sites.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a potential safety issue with medical devices where no injuries or illnesses have been reported, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare has initiated a recall of 9,369 MRI systems, including various SIGNA, Discovery, and Optima models, due to a potential safety issue. The recall is caused by software versions not being maintained properly at some sites.

The affected units were distributed worldwide, including the United States (nationwide, including PR, GU, and DC) and numerous international countries. The recall number is Z-1305-2015.

The source text does not specify specific actions for consumers or healthcare facilities, nor does it report any injuries or illnesses associated with this issue.

The recalled product

Product
GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5
Manufacturer
GE Healthcare
Category
Medical Device — MRI Systems
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Related recalls

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