Reported Jun 15, 2022 · Ongoing
Centricity PACS RA1000
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 RA1000
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 Software Version 3.0 through 3.2 SP8, No GTIN/DI (Code: 2051372-0XX, 2064678-0XX) 2 00840682124447Software Version 4.0 through 4.0 SP14, GTIN/DI 00840682124447 (Code: 2062264-0XX) 3 008406821048216.0 through 6.0 SP10.3, GTIN/DI: 00840682104821 (Code: 2094628-0XX) 4 008406821455587.0 through 7.0 SP0.0.4.7, GTIN/DI: 00840682145558 (Code: 5824366-0XX) - Amount recalled
- 676 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Potential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP, Distance and Area measurements can display inaccurate measurement values when performed on lossy images that are scaled down from their original resolution.
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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