Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software; GE Healthcare Integrated IT Solutions, Barrington, IL

FDA device recall Z-2316-2009 · posted 2009-09-24 · Terminated

Recall details

Recalling firm

GE Healthcare Integrated IT Solutions

Reason for recall

Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study split operations are not correctly replicated to a secondary 'shadow' archive.

Action taken

GE Healthcare Integrated IT Solutions sent Urgent Medical Device Correction letters dated August 7, 2009 to the attention to the Director of Radiology, the Hospital Administrator, the Head of the Radiology Department and the PACS Administrator. The letters advised users of the potential safety issue and provided safety instructions to follow until the software is updated. Users were asked to complete the enclosed Customer Reply form and fax the completed form to 1-847-939-1479. Any questions should be directed to the Remote Online Center or the GE Customer Care Center at 1-800-437-1171.

Root cause

Software design

Status

Terminated

Product code

LMB

Quantity affected

212 units

Distribution

Worldwide Distribution -- United States, Belgium, Canada, Cayman Islands, China, Denmark, France, Germany, Great Britain, Hong Kong, India, Israel, Italy, Korea, Malaysia, Malta, Mexico, New Zealand,

Date initiated

2009-08-14

Date posted

2009-09-24

Date terminated

2011-02-25

Location

Barrington, IL