Centricity Universal Viewer fails to save study changes to archive systems
GE Healthcare's Centricity Universal Viewer has a software defect where changes to radiological studies are not saved to archive systems, potentially affecting clinician access to current image data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with potential for diagnostic harm due to study changes not synchronizing to archive systems. No patient injuries or illnesses have been reported. The defect presents a risk-of-harm scenario where clinicians may access outdated archived images.
Plain-English summary
The Centricity Universal Viewer version 7.0 (Model 5829628-0XX), a radiological image processing system manufactured by GE Healthcare, has been recalled due to a software anomaly in its study management feature.
The defect prevents study changes from being synchronized to either the Centricity Enterprise Archive or other Vendor Neutral Archive systems. This means when technicians or clinicians modify radiological images or associated study data in the viewer, those changes do not propagate to the archive systems, where clinical staff may rely on the most current version of the study.
The affected software versions are 7.0 SP0.0.4.5 and 7.0 SP0.0.5. Approximately 49 units were distributed across eight U.S. states (Arkansas, Illinois, Maine, Mississippi, Nebraska, New Jersey, New York, and Tennessee) and fourteen countries internationally.
GE Healthcare and the FDA recommend that healthcare facilities contact the manufacturer for updated software or further guidance on managing affected systems.
The recalled product
- Product
- Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 49
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)
- Centricity Universal Viewer
- Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794
Distribution
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