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U.S. Department of Health and Human Services

Class 2 Device Recall Precision 500D Radiographic/Fluoroscopic Xray

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 Class 2 Device Recall Precision 500D Radiographic/Fluoroscopic Xraysee related information
Date Initiated by FirmDecember 30, 2004
Date PostedFebruary 14, 2006
Recall Status1 Terminated 3 on February 21, 2006
Recall NumberZ-0220-05
Recall Event ID 30761
510(K)NumberK011624 
Product Classification System, X-Ray, Fluoroscopic, Image-Intensified - Product Code JAA
ProductPrecision 500D Radiographic/Fluoroscopic X-ray System, model numbers 2225849, 005853. The Precision 500D system consists of an X-ray generator; angulating table with X-ray Tube, collimator and image intensifier; wall stand; overhead tube suspension; operator console and digital archive system.
Code Information all serial numbers
Recalling Firm/
Manufacturer		 General Electric Med Systems LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactLarry 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
ActionAn '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 Commerce921
Distributionglobally
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 = JAA
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