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

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
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Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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Corporate Office

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