PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 19, 2019 Initiated: May 22, 2019 #Z-1781-2019

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
620 units
Distribution
Worldwide
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
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. Recalled by GE Healthcare, LLC. Units affected: 620 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 19, 2019. Severity: Moderate. Recall number: Z-1781-2019.