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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 Recall
GE Centricity PACS RA1000 Workstation
see related information
Date Posted February 03, 2009
Recall Status1 Terminated on February 03, 2010
Recall Number Z-0970-2009
Recall Event ID 50759
Premarket Notification
510(K) Number
K043415 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product GE 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 Software versions 2.1.X and 3.0.X and higher with Talk Extend
Recalling Firm/
Manufacturer
GE Healthcare Integrated IT Solutions
540 W Northwest Hwy
Barrington, Illinois 60010-3051
For Additional Information Contact GE Customer Care Center
800-437-1171
Manufacturer Reason
for Recall
Unread exams may inadvertently get marked as dictated in PACS workstation when the user signs off the report in Talkstation and opens the next exam.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare Integrated IT Solutions notified their Centricity PACS RA1000 Workstation with Talk Extend software customers via letter (Urgent Medical Device Correction) dated 11/10/08 of the software anomaly resulting in a patient safety issue involving Talk Extend, which could contribute to a delay of care or misdiagnosis due to delay in communicating pertinent exam results or failure to treat due to lack of an attached dictated report by the radiologist for physician review. 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 Commerce 22 units
Distribution California, Florida, Illinois, Iowa, Louisiana, Oregon, Pennsylvania, Texas, Utah, Virginia and Wisconsin.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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