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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 May 01, 2008
Recall Status1 Terminated on May 17, 2010
Recall Number Z-1104-2008
Recall Event ID 46306
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
Code Information GE Centricity PACS RA1000 Workstation Software versions 2.1.X. and 3.0.X.
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
Report missing characters: Four special characters, when entered into the exam notes, are not transferred to the preview panel or hard copy printout (greater than [>], less than [<], quotation mark ["], and apostrophe [']). This may not be evident to the end user, as the symbols only appear when the Exam Note window is open.
FDA Determined
Cause 2
DESIGN: Software Design
Action GE Healthcare IITS sent Product Safety Notification letters dated 12/28/07 to all customers who have the GE Centricity PACS RA1000 Workstation software versions 2.1.X, or 3.0.X, informing them of the potential patient safety issue involving the exam notes window, which may be used to provide various patient information including lab results. To mitigate this problem, the users were instructed not to use the following four special characters (greater than sign >, less than sign <, double quotation mark " and apostrophe ') in the exam notes field in order to prevent any adverse patient events. For example, if a lab result was entered as GFR <60, it should be typed as GFR less than 60. The customers were requested to make sure that all necessary physicians and personnel at their location are made aware of the problem and the recommended actions provided. A software patch to permanently resolve the issue will be installed at no charge when it becomes available. Any questions were directed to the GE Customer Care Center at 800-437-1171.
Quantity in Commerce 557 units
Distribution Worldwide Distribution - USA, Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Kuwait, Malaysia, New Zealand, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
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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