GE Healthcare MRI Systems Recalled Due to Potentially Flipped Images
GE Healthcare has recalled 653 SIGNA MRI systems worldwide due to a potential defect that could flip medical images left to right. This could affect diagnostic accuracy in patient care.
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: This is a risk-of-harm medical device where potential image flipping could lead to diagnostic errors and patient harm. However, no illnesses, injuries, or hospitalizations have been reported. Per the rubric, risk-of-harm products without reported injuries score at 3 (High).
Plain-English summary
GE Healthcare, LLC has recalled 653 units of SIGNA magnetic resonance imaging (MRI) systems across multiple models and field strengths. The recalled systems include 1.5T and 3.0T SIGNA HDx, SIGNA HDxt, and 1.5T SIGNA HDxt Mobile models. The recall addresses a potential defect in which medical images produced by the systems could be flipped horizontally, reversing the left-right orientation of anatomical structures.
The affected systems have been distributed worldwide, including to healthcare facilities throughout the United States and in 40 additional countries including Argentina, Australia, Canada, China, France, Germany, India, Japan, Mexico, and the United Kingdom, among others. Units are identified by specific system IDs provided by GE Healthcare.
Healthcare facilities and providers using these systems should verify images produced by their equipment and contact GE Healthcare for guidance on remediation. Any diagnostic studies performed with these systems should be reviewed and corrected if image flipping has occurred, as reversed imaging could lead to diagnostic errors and impact patient care decisions.
The recalled product
- Product
- 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System
- Manufacturer
- GE Healthcare, LLC
- Hazard
- image-flipping
- diagnostic-error
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 (20)
- System IDs: 907562P3T
- 256734MR3T
- 623879MR1
- 623433MR1
- 480584MR1
- 602689MR1
- 9287573TMR
- 480324MR1
- 480614MR1
- 928317MR1
- 714868MR1
- RADNETMR615
- 714619MR
- 5107923TMR
- 858657MR1
- 323442MR3
- 323442MR1
- 213977MR2
- 323932MR1
- 323442MR2
Distribution
Distributed nationwide across the United States.
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