GE Healthcare, LLC: GE Centricity Universal Viewer Zero Footprint Client

Is my product affected?

GE Centricity Universal Viewer Zero Footprint Client

• UPC 00840682102988

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare has recalled 638 units of its Centricity Universal Viewer Zero Footprint Client software worldwide due to a potential issue where the software may display incomplete patient imaging studies. The affected versions are 6.0 SP9 through SP10.2.2.1 when configured with a Centricity PACS back end. The software has been distributed across numerous U.S. states and multiple countries internationally.

The recall notice does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is a potential to display incomplete patient imaging study.

Details from the source

Reason for recall: There is a potential to display incomplete patient imaging study. Distribution: Worldwide distribution - US Nationwide distribution in the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, WA, and WV. The countries of Argentina, Aruba, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Ecuador, France, Germany, India, Indonesia, Ireland, Israel, It Quantity: 638 devices Lot/code info: Versions 6.0 SP9, SP9.0.1, SP9.0.1.1, SP9.0.1.2, SP9.0.1.3, SP9.0.1.4, SP9.0.1.5, SP10, SP10.1, SP10.2, SP10.2.1, SP10.2.1.1, SP10.2.2, SP10.2.2.1 configured with a Centricity PACS back end. GTIN 00840682102988; UDI 00840682102988.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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