Signa 1.5T MRI System Recall: Potential Horizontal Image Reversal
GE Healthcare is recalling 10 Signa 1.5T TwinSpeed MRI systems worldwide due to a potential defect where magnetic resonance images may be flipped left to right.
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: This is a Class II medical device recall with a potential defect affecting diagnostic image orientation. While the defect is theoretical with no reported illnesses or injuries documented, it presents a risk-of-harm to patient care through compromised diagnostic accuracy. The absence of confirmed harm with a theoretical hazard places it in the High severity tier per the rubric.
Plain-English summary
GE Healthcare, LLC is recalling the Signa 1.5T TwinSpeed Magnetic Resonance Imaging System due to a potential defect: the system's images may be flipped horizontally from left to right.
The recall involves 10 units distributed worldwide to the United States and numerous international locations, including Canada, Mexico, the United Kingdom, Germany, France, Italy, Japan, Brazil, and Australia, among others across multiple continents.
Image orientation is essential to diagnostic accuracy in MRI systems, making this potential defect significant for affected healthcare facilities using the recalled equipment.
The recalled product
- Product
- Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- System IDs: MMIMR01
- 213748HDMR
- 714125MR
- 561218MR1
- 918523MR1
- 304766MR1
- 082427030026
- 082427080007
- 082427020017
- 376569401MR
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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