GE Healthcare Integrated IT Solutions GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS 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 us Recall
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According to the U.S. Food and Drug Administration (FDA)
Product
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT Solutions, Barrington, IL 60010. The Centricity PACS 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 us
Brand
GE Healthcare Integrated IT Solutions
Lot Codes / Batch Numbers
Software version 2.1.5.5 and 3.0.4 and higher.
Products Sold
Software version 2.1.5.5 and 3.0.4 and higher.
GE Healthcare Integrated IT Solutions is recalling GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integrated IT due to There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is a potential patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed.
Recommended Action
Per FDA guidance
GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 11/21/08 of the software anomaly resulting in a patient safety issue involving patient jacket content, which may result in unintended historical image(s) being displayed. The letter provided the users with safety instructions to follow until the software is updated. Please direct any questions to the Remote Online Center, Field Engineer or the GE Customer Care Center at 800-437-1171. The accounts were requested to complete the enclosed customer reply form, supplying the workstation software or build number, and fax the completed form to 414-918-4653.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026