Recall Z-1233-2022— GE Healthcare, LLC

Name: FDA recall Z-1233-2022
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. It names one FDA 510(k) clearance: K110875. Product: Centricity PACS RA1000. 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

510(k) clearances named in this recall

1 on FDA's record

K110875 — CENTRICITY PACSGE Healthcare·cleared 2011-05-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Centricity PACS RA1000

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.