Recall Z-0023-2016— GE Healthcare

Name: FDA recall Z-0023-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-16

Class II · Terminated

Class II FDA medical device recall by GE Healthcare, initiated 2015-09-16, terminated 2017-01-05. It names 2 FDA 510(k) clearances: K121387, K082318. Product: Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.. Reason: Images may be missing when a system parameter MapRoute is set to a value greater than 1..

Recalling firm: GE Healthcare
Classification: Class II
Status: Terminated
Initiated: 2015-09-16
Terminated: 2017-01-05
Firm location: Barrington, IL, United States

510(k) clearances named in this recall

2 on FDA's record

K121387 — CENTRICITY PACS-IWGe Healthcare Integrated IT Solutions·cleared 2012-06-05
K082318 — CENTRICITY PACS IWGe Healthcare Dynamic Imaging Solutions·cleared 2008-08-25

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 IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

Reason for recall

Images may be missing when a system parameter MapRoute is set to a value greater than 1.

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