GE SIGNA Artist MRI System May Produce Incomplete Image Scans
GE Healthcare recalls 18 SIGNA Artist MRI systems with a software defect that may cause missing image slices, creating gaps in 3D scans that could affect diagnostic accuracy.
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 an FDA Class II medical device recall involving a software defect that creates diagnostic imaging gaps. Although no illnesses or injuries have been reported, the defect could impact diagnostic accuracy and patient care outcomes, warranting a High severity classification per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 18 SIGNA Artist nuclear magnetic resonance (MRI) imaging systems due to a software defect in version DV29.1. Under certain operating conditions, the system may fail to capture some image slices, resulting in gaps in the reconstructed 3D volume images.
The defect can create gaps in anatomical imaging data, potentially impacting diagnostic accuracy. Clinicians relying on the 3D volume images for diagnosis may encounter incomplete anatomical information, though no patient injuries or illnesses have been reported to date.
The affected devices were distributed to hospitals and medical facilities across 18 U.S. states and Puerto Rico, as well as 16 countries internationally. If you operate a SIGNA Artist system with software version DV29.1, contact GE Healthcare for information on available software updates or corrective actions. Healthcare facilities should review their devices and implement any patches or updated clinical protocols recommended by the manufacturer.
The recalled product
- Product
- SIGNA Artist nuclear magnetic resonance imaging system
- Manufacturer
- GE Healthcare, LLC
- Hazard
- imaging-defect
- diagnostic-accuracy
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 (1)
- Software version DV29.1
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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