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U.S. Department of Health and Human Services

Class 2 Device Recall Definium 5000 Xray System

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 Class 2 Recall
Definium 5000 Xray System
see related information
Date Posted September 25, 2009
Recall Status1 Open
Recall Number Z-1118-2009
Recall Event ID 51490
Premarket Notification
510(K) Number
K063283 
Product Classification System, X-Ray, Stationary - Product Code KPR
Product Definium 5000 X-ray System, model number 5220493 and 5220393-2
Code Information Serial Numbers: 00000GEHC00049, 00000GEHC00011, 00000GEHC00009 00000GEHC00035 00000GEHC00041 00000GEHC00028 00000GEHC00026 00000GEHC00078 00000GEHC00051 00000GEHC00043 00000GEHC00008 00000GEHC00016 00000GEHC00013 00000GEHC00058 00000GEHC00110 00000GEHC00120 00000GEHC00042 00000GEHC00047 00000GEHC00069 00000GEHC00057 00000GEHC00019 00000GEHC00066 00000GEHC00085 00000GEHC00046 00000GEHC00076 00000GEHC00015 00000GEHC00018 00000GEHC00124 00000GEHC00095 00000GEHC00022 00000GEHC00100 00000GEHC00125 00000GEHC00117 00000GEHC00027 00000GEHC00112 00000GEHC00054 00000GEHC00062 00000GEHC00119 00000GEHC00118 00000GEHC00048 00000GEHC00089 00000GEHC00114 00000GEHC00121 00000GEHC00107 00000GEHC00108 00000GEHC00036 00000GEHC00030 00000GEHC00045 00000GEHC00017 00000GEHC00064 00000GEHC00075 00000GEHC00077 00000GEHC00115 00000GEHC00053 00000GEHC00106 00000GEHC00007 00000GEHC00021 00000GEHC00023 00000GEHC00065 00000GEHC00020 00000GEHC00083 00000GEHC00105 00000GEHC00111 00000GEHC00031 00000GEHC00025 00000GEHC00104 00000GEHC00067 00000GEHC00133 00000GEHC00101 00000GEHC00072 00000GEHC00024 00000GEHC00087 00000GEHC00059 00000GEHC00012 00000GEHC00068 00000GEHC00034 00000GEHC00123 00000GEHC00073 00000GEHC00050 00000GEHC00113 00000GEHC00052 00000GEHC00006 00000GEHC00005 00000GEHC00131, and 00000GEHC00131.
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
A defect in the AEC board in the system's control causes failure to terminate additional exposures at the exposure time selected for the initial exposure.
FDA Determined
Cause 2
RADIATION CONTROL FOR HEALTH AND SAFETY ACT: Radiation Control for Health and Safety Act
Action A notification was sent to all affected customer sites alerting them to this issue, with instructions for safe use of the affected systems.
Quantity in Commerce 85
Distribution Nationwide Distribution
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 = KPR and Original Applicant = SEDECAL S.A.
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