Reported Sep 29, 2021 · Ongoing
Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medical images (including…
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-IW
- with Universal Viewer - Product UsageIs a device that displays medical images (including mammograms) and data from various imaging sources
- Lot codes and dates
- 2068177-001 (Centricity PACS-IW with Universal Viewer software versions 5.0
- x with PACS-IW foundation) System ID
0830552484814161-1219672671-429329281DGC19607785HC3062UV01HCIT1401012UWHCIT4331279UVPACS-IW-127PACS-IW-219PACS-IW-2770PACS-IW-323PACS-IW-421RICHMONDU14767331RICHMONDU15531177N1X1347906 / X1347909X1347906 / X1347909YP315021ZA2412PAC21 and ZA2533PAC1
- Amount recalled
- 392 (219 US; 173 OUS) all products
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
Image acquisition failures and synchronization failure with the Centricity Enterprise 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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