GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare Integrated IT Solutions, Barring

FDA device recall Z-1549-2009 · posted 2009-07-01 · Terminated

Recall details

Recalling firm

GE Healthcare Integrated IT Solutions

Reason for recall

There is a potential safety issue associated with the use of GE Centricity PACS software related to configuration of DICOM query retrieval with rejected images.

Action taken

GE Healthcare Integrated IT Solutions sent an "Urgent Medical Device Correction" letter dated April 2, 2009 to their Centricity PACS software versions 2.1.x and 3.0.x customers with 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 patient safety issue associated with the affected device and provided safety instructions to follow until the software is updated. User were asked to complete the enclosed Customer Reply form and fax the completed form to 1-847-939-1479. Centricity PACS Software Versions 1.0.x and 2.0.x customers were sent separate letters explaining the issue and the safety instructions to follow, but there will be no software updates since those software versions are no longer being supported. Any questions should be directed to the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

1,188 units

Distribution

Worldwide Distribution - United States including Puerto Rico and countries of Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Ireland, I

Date initiated

2009-04-03

Date posted

2009-07-01

Date terminated

2012-05-25

Location

Barrington, IL

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