Recall Z-1230-2022— GE Healthcare, LLC

Name: FDA recall Z-1230-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-28

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2022-04-28. FDA's recall record names no specific 510(k) clearance for this event. Product: Centricity Enterprise Web. Reason: 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..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-04-28
Firm location: Waukesha, WI, United States

Product description

Centricity Enterprise Web

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.