Recall – PACS viewer missing images without warning

Company: GE Healthcare, LLC
Date of Enforcement Report: 6/19/2019
Class II

PRODUCT

GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

Recall Number: Z-1781-2019

REASON

There is a potential that one or more image series (i.e., all images within an image set) may be missing from an exam without a warning displayed in the viewer.

RECALLING FIRM/MANUFACTURER

GE Healthcare, LLC on 6/19/2019. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
620 units

DISTRIBUTION

US Nationwide and International

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.