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Class 2 Device Recall GE Centricity PACS RA1000 Workstation |
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Date Initiated by Firm |
November 20, 2008 |
Date Posted |
February 03, 2009 |
Recall Status1 |
Terminated 3 on February 03, 2010 |
Recall Number |
Z-0970-2009 |
Recall Event ID |
50759 |
510(K)Number |
K043415
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Product Classification |
Picture Archiving and Communication System - Product Code LLZ
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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 IL 60010-3051
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For Additional Information Contact |
GE Customer Care Center 800-437-1171
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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.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
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