GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The intended use:The Centri

FDA device recall Z-1394-2010 · posted 2010-04-15 · Terminated

Recall details

Recalling firm

Ge Healthcare It

Reason for recall

There is a potential safety issue associated with the use of GE Centricity PACS-IW and PACS Web Diagnostic software related to use of built-in reconstruction functions which may result in incorrect anatomic orientation markers.

Action taken

An "Urgent Medical Device Correction" letters dated February 18, 2010 to their Centricity PACS-IW software version 3.x customers and Centricity PACS Web Diagnostic software version 3.7.4.x customers, The letters advised the users of the patient safety issues associated with the use of the software when using built-in reconstruction functions, which may result in incorrect anatomic orientation markers. The separate letters provided the users with specific safety instructions for that software version to follow until the software is updated. The customers were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 847-939-1479. Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

634 units

Distribution

Worldwide distribution: USA and Australia, Austria, Belgium, Canada, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Japan, Korean, Kuwait, Latvia, Lebanon, Libya, Lithuania, Malaysi

Date initiated

2010-02-18

Date posted

2010-04-15

Date terminated

2016-06-10

Location

Barrington, IL

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