GE Healthcare Integrated IT Solutions: GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.

Recall number

Z-1543-2009

Recalling firm

GE Healthcare Integrated IT Solutions

Product

GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS (Picture Archiving and Communication System) Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.

Status

Terminated

Initiated

2009-03-24

Posted

2009-07-13

Terminated

2010-09-06

Reason

Software anomalies may allow the image orientation to be misinterpreted, posing a potential patient safety issue.

Root cause

Software design

Action

GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation Software Versions 2.1.x and 3.0.x customers via an Urgent Medical Device Correction notice dated March 2, 2009 of the affected device resulting in patient safety issues. The letter provided users with safety instructions until the software is updated. Consignees are requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 1-847-939-1479. Centricity PACS RA1000 Workstation Software Versions PathSpeed 7.x, 8.x, Centricity 1.X and 2.0.X customers were sent separate letters explaining the recall including instructions. There will be no software updates since those software versions are no longer being supported. For questions, call the Remote Online Center, Field Engineer or the GE Customer Care Center at 1-800-437-1171.

Quantity

984 units

Distribution

Worldwide Distribution - US including Puerto Rico and countries of Brazil, Canada, Chile, Ecuador, Mexico, Australia, China, Hong Kong, Japan, Korea, Malaysia, New Zealand, Singapore, Taiwan, Austria, Belgium, Switzerland, Germany, Denmark, Egypt, Spain, France, Great Britain, Ireland, Israel, Italy, Kuwait, Lebanon, Malta, Netherlands, Portugal, Saudi Arabia, Sweden and Turkey.

Lot, serial or model codes

Software Versions: Centricity 1.X, 2.0.X, 2.1.X and 3.0.X and PathSpeed 7.X and 8.X.

510(k) numbers

["K043415"]

PMA numbers

not on file

Product code

LLZ

Firm FEI

3004526608

Firm city

Barrington

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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