MRI System Software Defect May Cause Missing Anatomical Image Data
GE Healthcare's SIGNA Architect MRI system may fail to generate complete image slices under certain software conditions, resulting in gaps within 3D volume images that could affect diagnostic imaging integrity.
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 medical device recall with a functional defect impacting diagnostic imaging quality. This represents a risk-of-harm product where injury has not been reported, meeting the rubric criteria for Score 3.
Plain-English summary
GE Healthcare's SIGNA Architect nuclear magnetic resonance imaging system is the subject of a Class II recall. Two devices with software versions DV29.1, DV28.4 (F), or DV27.3 (T) are affected.
Under certain conditions, these systems may fail to generate all required image slices, resulting in gaps within the 3D volume images. This missing anatomical data could impact the completeness of diagnostic imaging studies.
The affected devices have been distributed in the United States across multiple states and Puerto Rico, as well as internationally including 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 Architect nuclear magnetic resonance imaging system
- Manufacturer
- GE Healthcare, LLC
- Hazard
- imaging-defect
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 DV29.1
- and DV28.4 (F)
- DV27.3 (T) (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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