Recall Z-1911-2019— GE Healthcare, LLC

Name: FDA recall Z-1911-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-16

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2019-05-16, terminated 2023-04-14. It names one FDA 510(k) clearance: K110875. Product: Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.. Reason: There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-05-16
Terminated: 2023-04-14
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 Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.

Reason for recall

There is the possibility of viewing studies directly from the Enterprise Archive or VNA with incorrect patient images because the updated series or study is not present in the archive.

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