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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 FirmDecember 28, 2007
Date PostedMay 01, 2008
Recall Status1 Terminated 3 on May 17, 2010
Recall NumberZ-1104-2008
Recall Event ID 46306
510(K)NumberK043415 
Product Classification patient image workstation - Product Code LLZ
ProductGE 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 IL 60010-3051
For Additional Information ContactGE 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		Software design
ActionGE 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 Commerce557 units
DistributionWorldwide 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 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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