Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiv

FDA device recall Z-2469-2015 · posted 2015-08-27 · Terminated

Recall details

Recalling firm

GE Healthcare

Reason for recall

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.

Action taken

The firm sent out an Urgent Medical Device Correction letter dated 8/11/2015 to all affected customers. Letter states that No User activity required. GE Healthcare has completed a remote inspection of your system and found that this system parameter is currently set to the default setting of 1. The firm will correct all affected systems by a providing software update. The letter also states that if the customer has any questions they should call GE Healthcare Service at 1-800-437-1171 or their local service representative.

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

LLZ

Quantity affected

82 systems

Distribution

Worldwide Distribution - U.S. nationwide in the states of: AK, CA, CO, DE, FL, HI, ID, NY, PA, SD, TN and TX; France, Germany, Greece, India, Israel, Malaysia, Mexico, Northern Ireland (UK), Panama, P

Date initiated

2015-08-11

Date posted

2015-08-27

Date terminated

2017-01-05

Location

Barrington, IL