Reported Aug 31, 2022 · Ongoing
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX;…
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?
(1) GE Centricity Universal Viewer 6.0Model 2088026-9XX(2) GE Centricity Universal Viewer 7.0Model 5826659-0XX(3) GE Universal Viewer 8.0Model 5865740-00x
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 00840682103800(1) Centricity Universal Viewer 6.0 - UDI 00840682103800 2 0084068214579400840682145558Software versions 6.0 SP9, 6.0 SP9.0.1 through 6.0 SP9.0.1.11, 6.0 SP9.0.2, and 6.0 SP10 through 6.0 SP10.4. (2) Centricity Universal Viewer 7.0 - UDI 00840682145794, 00840682145558 3 00195278379610Software versions 7.0 through 7.0 SP0.0.4.9, 7.0 SP0.0.5, 7.0 SP0.1.0, and 7.0 SP1. (3) Universal Viewer 8.0 - UDI 00195278379610 4 Software versions 8.0, 8.0 SP0.1.0, and 8.0 SP0.1.1. - Amount recalled
- 1,690 devices
Where it was sold
Why it was recalled
Inaccurate Distance and Area measurements with use of Global Stack viewport.
This product could cause temporary or reversible health problems — stop using it.
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