Recall Z-2469-2015— GE Healthcare

Class II FDA medical device recall by GE Healthcare, initiated 2015-08-11, terminated 2017-01-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology.. Reason: Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer 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

2015-08-11

Terminated

2017-01-05

Firm location

Barrington, IL, United States

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