FDA recall Z-1781-2019

GE Healthcare, LLC · Class II · device

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

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.

Distribution

Worldwide

Key facts

Status: Terminated
Initiation date: 2019-05-22
Report date: 2019-06-19
Termination date: 2024-09-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1781-2019