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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus

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  Class 2 Device Recall Proteus see related information
Date Initiated by Firm November 01, 2007
Date Posted June 10, 2008
Recall Status1 Terminated 3 on December 18, 2011
Recall Number Z-0842-2008
Recall Event ID 46859
510(K)Number K993090  
Product Classification x-ray system - Product Code KPR
Product GE Healthcare Proteus XR/a Radiographic X-ray System, Model Number 2259976; previously marketed as the Silhouette FC, GE Healthcare, Waukesha, WI 53188.
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Recalling Firm/
Manufacturer		 GE Healthcare
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall		 The warning label that is required by 21 CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic X-ray System, Model 2259976.
FDA Determined
Cause 2		 Process control
Action GE issued a Field Modification Instruction to their field service representatives, released in December 2007, with instructions to replace the labels on the console with the appropriate labeling. Consignees will be visited by GE field service representatives beginning December 2007. All consignees will have the required labels affixed to their units by July 31, 2008.
Quantity in Commerce 400 Units
Distribution Worldwide Distribution, including USA, Canada, Mexico, France, Hong Kong, Italy, Korea, China, Poland, UK, New Zealand, Saudi Arabia, Taiwan, Turkey, and Australia.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KPR and Original Applicant = GE MEDICAL SYSTEMS, INC.
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