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FDA (Device enforcement)Recalled 2022-04-28class ii

GE Healthcare, LLC: Centricity Universal Viewer Zero Footprint Client

Is my product affected?

Centricity Universal Viewer Zero Footprint Client

  • UPC 00840682102988

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

What happened

GE Healthcare, LLC has recalled its Centricity Universal Viewer Zero Footprint Client software because Distance and Area measurements may display inaccurate values when performed on magnified images. Additionally, for the Zero Footprint Client specifically, these measurements can show inaccurate values when performed on lossy images that have been scaled down from their original resolution. The affected software includes Version 6.0 SP11 through 6.0 SP11.4, and approximately 488 units were distributed worldwide and throughout all U.S. states, as well as internationally to countries including Canada, Australia, Brazil, and China.

The record does not specify a remedy or instructions for affected consumers regarding what steps they should take in response to this recall.

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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Nationwide distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. International distribution to Argentina, Australia, Austria, Bahamas, Belgium, Bermuda, Bolivia, Plurinational State of, Brazil, Canada, Chile, China Quantity: 488 units Lot/code info: Software Version 6.0 SP11 through 6.0 SP11.4; GTIN/DI: 00840682102988; Codes: 2089507-1XX

Source

Official record: FDA (Device enforcement) ↗

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

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