GE Healthcare SIGNA Voyager MRI System Recall for Missing Image Slices
GE Healthcare is recalling the SIGNA Voyager nuclear magnetic resonance imaging system due to a software issue that can cause missing slices in 3D volume images, potentially creating gaps in anatomical information.
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 device experiences a software defect resulting in missing slices in 3D volume images, creating gaps in diagnostic anatomical information. While this poses a risk of patient harm through incomplete diagnostic data, no illnesses or injuries have been reported. The FDA Class II classification without reported hospitalization supports a High severity rating under the rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling the SIGNA Voyager nuclear magnetic resonance imaging system. The recall affects software versions VX29.1 and PX26.4 (China only) and involves 15 devices in total.
Under certain conditions, the imaging system may produce 3D volume images with missing slices, creating gaps in anatomical information. This defect could affect the completeness and accuracy of diagnostic imaging.
The affected devices were distributed in the United States to Arizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Texas, Virginia, Washington, and Puerto Rico. Outside the United States, devices were distributed to Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, the United Arab Emirates, and the United Kingdom.
The recalled product
- Product
- SIGNA Voyager nuclear magnetic resonance imaging system
- Manufacturer
- GE Healthcare, LLC
- Hazard
- missing-slices
- diagnostic-inaccuracy
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 (2)
- Software version VX29.1
- and PX26.4 (China only)
Distribution
Distributed in 18 states:
- AZ
- CA
- FL
- GA
- IL
- LA
- MA
- MD
- MN
- NC
- NH
- NJ
- NY
- OH
- OK
- TX
- VA
- WA
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