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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- GE Healthcare
- Category
- Medical Device — MRI Systems
- Hazard
Distribution
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