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U.S. Department of Health and Human Services

Class 2 Device Recall GE Centricity PACS RA1000 Workstation

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 Class 2 Device Recall GE Centricity PACS RA1000 Workstationsee related information
Date Initiated by FirmJanuary 12, 2009
Date PostedFebruary 03, 2009
Recall Status1 Terminated 3 on September 06, 2010
Recall NumberZ-0969-2009
Recall Event ID 50758
510(K)NumberK043415 
Product Classification Picture archiving and communications system - Product Code LLZ
ProductGE Centricity PACS RA1000 Workstation (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.
Code Information All software versions
Recalling Firm/
Manufacturer		 GE Healthcare Integrated IT Solutions
540 W Northwest Hwy
Barrington IL 60010-3051
For Additional Information ContactGE Customer Care Center
800-437-1171
Manufacturer Reason
for Recall		If a user site created a custom default display protocol (DDP) to display the current exam versus the historical exam and the user-defined DDP fails, the system displays the exams using a GE default hanging protocol. This may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars.
FDA Determined
Cause 2		Software design
ActionGE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation software customers via letter (Urgent Medical Device Correction) dated 1/12/09 of the software anomaly resulting in a patient safety issue involving Default Display Protocols. The issue may create a potential for misdiagnosis if the user does not review the date and time stamps in the title bars. The letter provided the users with safety instructions to follow until the software is updated. Any questions were directed 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 847-939-1479.
Quantity in Commerce778 units
DistributionNationwide, Canada, Bermuda, Mexico, Ecuador, Chile, and Brazil
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LLZ
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