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U.S. Department of Health and Human Services

Class 2 Device Recall Proteus XR/a Radiographic Xray System

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  Class 2 Device Recall Proteus XR/a Radiographic Xray System see related information
Date Initiated by Firm December 30, 2004
Date Posted February 14, 2006
Recall Status1 Terminated 3 on February 21, 2006
Recall Number Z-0219-05
Recall Event ID 30761
510(K)Number K993090  
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Proteus XR/a Radiographic X-ray System, models 2259973-1, 2259973-2, 2259973-3, 2259973-4. The system consists of a radiographic table, a overhead tube suspension, high frequency generator and power distribution unit, wall stand, dual focal spot x-ray tube and operator''s console.
Code Information all serial numbers
Recalling Firm/
Manufacturer		 General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact Larry Kroger, Ph.D
262-544-3894
Manufacturer Reason
for Recall		 Units have a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.
FDA Determined
Cause 2		 Other
Action An 'Urgent: Radiation Safety Notice' letter was issued to hospitals with affected systems describing potential hazards, the planned modification and recommended action to limit the hazard until the planned modification is installed. A GE field Service Representative will install the modification.
Quantity in Commerce 2716
Distribution globally
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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