GE Centricity Medical Imaging Software May Display Incomplete Patient Studies
GE Healthcare recalled versions of Centricity Universal Viewer Zero Footprint Client software due to a potential defect that could display incomplete patient imaging studies. No injuries have been reported.
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: This FDA Class II recall involves a medical imaging software defect with potential to affect diagnostic accuracy. While no injuries or illnesses have been reported and the hazard is theoretical, incomplete patient imaging data poses a risk of patient harm through inaccurate diagnosis.
Plain-English summary
GE Healthcare, LLC has recalled the Centricity Universal Viewer Zero Footprint Client software, versions 6.0 SP9 through SP10.2.2.1 when configured with a Centricity PACS backend. A total of 638 devices have been affected. This medical imaging viewer is used in clinical settings worldwide.
The software has a potential defect that could cause it to display incomplete patient imaging studies. No injuries or illnesses related to this issue have been reported to date.
The affected software has been distributed worldwide, with use across the United States and in numerous other countries including Canada, Australia, the United Kingdom, France, Germany, Italy, Spain, and others.
The recalled product
- Product
- GE Centricity Universal Viewer Zero Footprint Client
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 638
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 (15)
- Versions 6.0 SP9
- SP9.0.1
- SP9.0.1.1
- SP9.0.1.2
- SP9.0.1.3
- SP9.0.1.4
- SP9.0.1.5
- SP10
- SP10.1
- SP10.2
- SP10.2.1
- SP10.2.1.1
- SP10.2.2
- SP10.2.2.1 configured with a Centricity PACS back end. GTIN 00840682102988
- UDI 00840682102988.
Distribution
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