MRI System Recall: GE Healthcare SIGNA HDxt Missing Image Slices
GE Healthcare is recalling the 1.5T SIGNA HDxt MR System due to a software issue that may cause missing slices in 3D volume images. Three devices distributed across the United States and internationally are affected.
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 no reported illnesses or injuries. The hazard—missing image slices that could compromise diagnostic accuracy—is theoretical without documented adverse outcomes. Per the rubric, this qualifies as High (3).
Plain-English summary
GE Healthcare, LLC is recalling the 1.5T SIGNA HDxt MR System, a nuclear magnetic resonance imaging system used for diagnostic medical imaging. Three devices are affected by this recall.
Under certain conditions, the affected systems may produce missing slices in 3D volume images, resulting in gaps of anatomical information. This software defect impacts versions HD29.1 and HD16.2.
The affected devices were distributed to healthcare facilities in the United States in 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. The systems were also distributed internationally to Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, United Arab Emirates, and the United Kingdom.
The recalled product
- Product
- 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
- Manufacturer
- GE Healthcare, LLC
- Hazard
- missing-slices
- 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 (2)
- Software version HD29.1
- and HD16.2 (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
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03