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Terminated

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.

FDA Recall Z-1543-2009 · Posted 2009-07-13

Recall StatusTerminated
Product CodeLLZ
Date Initiated2009-03-24
Date Terminated2010-09-06
Product Quantity984 units

Reason for Recall

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

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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