Reported Jul 10, 2019 · Terminated
Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review,…
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 PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
- Lot codes and dates
- UDI # 840682104807 Model # 2098268-001 Software Version CPACS 6.0 SP9, CPACS 6.0 SP9.0.1 and CPACS 6.0 SP9.0.1.5
- Amount recalled
- 92 (47 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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