Reported Jul 10, 2019 · Terminated
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
- Lot codes and dates
- UDI # 840682103800 Model # 2098249-002
- Software Version
6.0.96.0SP9.01CPACS 6.0 SP9.0.1UV 6.0 SP9.0.1UV 6.0 SP9.01.1UV 6.0 SP9.0.1.2UV 6.0 SP9.01.3UV6.0 SP9.01.4UV 6.0 SP9.01.5UV 6.0 SP9.0.1.6UV Version 6.0 SP5.0.4.1UV Version 6.0 SP9UV Version 6.0 SP9.0.0.1UV Version 6.0 SP901UV Version 6.0 SP9011and UV Version 6.0 SP902
- Amount recalled
- 145 (87 US 103 OUS)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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