GE SIGNA Pioneer MRI Recall for Missing Image Slices
GE Healthcare is recalling 5 SIGNA Pioneer MRI systems where a software issue can cause missing image slices in 3D volume scans. This may lead to diagnostic gaps.
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: FDA Class II device recall with no reported illnesses or injuries. The hazard involves diagnostic imaging quality (missing image slices), representing a risk of patient harm through potential misdiagnosis, but no actual injuries have been reported.
Plain-English summary
GE Healthcare, LLC is recalling 5 SIGNA Pioneer MRI systems due to a software issue that can cause missing image slices in 3D volume imaging studies. Affected versions include PX29.1, PX25.4 (T), and PX28.3 (China only).
Under certain conditions, some slices may be missing from 3D volume images, creating gaps in anatomical coverage and potentially affecting diagnostic quality and accuracy.
The affected systems were distributed throughout the United States (including 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) and internationally 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.
Customers using affected systems should contact GE Healthcare for information on software updates or other corrective measures.
The recalled product
- Product
- SIGNA Pioneer nuclear magnetic resonance imaging system
- Manufacturer
- GE Healthcare, LLC
- Hazard
- diagnostic-inaccuracy
- incomplete-imaging
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 (3)
- Software version PX29.1
- and PX25.4 (T)
- PX28.3 (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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