The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare

FDA device recall Z-0454-2014 · posted 2013-12-05 · Terminated

Recall details

Recalling firm

Ge Healthcare It

Reason for recall

GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for embedding DICOM images as JPEGs on a web page and is available as a licensed operation on Centricity Web. When rejected images are archived by Centricity PACS to Enterprise Archive, an

Action taken

Urgent Medical Device Correction letters dated April 19, 2013 were sent to customers. The letter requests that customers ensure that their system is configured to disable the WADO interface using the included instructions until the software revision can be installed at their site. The letter further informs customers that updated software will be sent to them for installation.The software has been modified to correct these defects. The modified software will be released and installed in user sites through GE Healthcare FMI# 85206R.

Root cause

Software design

Status

Terminated

Product code

LMD

Quantity affected

53 units

Distribution

US Distribution incluidng states of: CA, FL, GA, IA, IL, LA, MO, NJ, NY, OK, TN, WA, and WI.

Date initiated

2012-04-19

Date posted

2013-12-05

Date terminated

2017-12-13

Location

Barrington, IL