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U.S. Department of Health and Human Services

Class 2 Device Recall GammaWin

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  Class 2 Device Recall GammaWin see related information
Date Initiated by Firm May 01, 2006
Date Posted July 27, 2006
Recall Status1 Terminated 3 on May 18, 2007
Recall Number Z-1268-06
Recall Event ID 35694
510(K)Number K983436  
Product Classification radiation therapy - Product Code JAQ
Product GammaWin software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus radionuclide applicator system, for radiation therapy.
Code Information All lots are recalled. Serial numbers are described: H64Y001 H64A032 H64A052 H64B074 H64C096  H64D120 H64Y002 H64A033 H64A053 H64B075  H64C097 H64D121 H64Y003 H64A034 H64A054  H64B076 H64C098 H64D122 H64Y006 H64A035  H64A055 H64B077 H64C099 H64D123 H64Y007  H64A036 H64A056 H64B078 H64C100 H64D124  H64Y009 H64A037 H64A057 H64B079 H64C101  H64D127 H64Y012 H64A038 H64A058 H64B080  H64C102 H64D128 H64Y013 H64A039 H64A059  H64B081 H64C103 H64D129 H64Z015 H64A040  H64A060 H64B082 H64C104 H64D130 H64Z018  H64A041 H64A061 H64B083 H64C106 H64D131 H64Z019 H64A042 H64A062 H64B084 H64C107  H64D132 H64Z021 H64A043 H64A063 H64B085  H64C108 H64D133 H64Z022 H64A044 H64A064  H64B087 H64C109 H64D134 H64Z024 H64A045  H64A066 H64B088 H64C110 H64D135 H64Z025  H64A046 H64A067 H64B089 H64C112 H64D136 H64Z026 H64A047 H64A068 H64B090 H64C113  H64E137 H64Z027 H64A048 H64B070 H64B091  H64D115 H64E138 H64Z028 H64A049 H64B071  H64C093 H64D116 H64E140 H64Z029 H64A050  H64B072 H64C094 H64D117 H64E141 H64Z030  H64A051 H64B073 H64C095 H64D118 H64E142 H64E143 H64E166 H64F191 H64F211 H640234  H640254 H64E147 H64E167 H64F192 H64F212  H640235 H640255 H64E148 H64E168 H64F193  H64F213 H640236 H640256 H64E149 H64E169  H64F194 H64F216 H640237 H640257 H64E150  H64E170 H64F195 H640217 H640238 H640258 H64E151 H64E171 H64F196 H640218 H640239  H640259 H64E152 H64E172 H64F197 H640219  H640240 H640260 H64E153 H64E173 H64F198  H640220 H640241 H640261 H64E154 H64E175  H64F199 H640221 H640242 H640262 H64E155  H64E176 H64F200 H640222 H640243 H640264 H64E156 H64E177 H64F201 H640224 H640244 H640265 H64E157 H64E178 H64F202 H640225  H640245 H640266 H64E158 H64E179 H64F203  H640226 H640246 H640267 H64E159 H64E180  H64F204 H640227 H640247 H640268 H64E160  H64F181 H64F205 H640228 H640248 H640269 H64E161 H64F182 H64F206 H640229 H640249 H640270 H64E162 H64F183 H64F207 H640230  H640250 H640271 H64E163 H64F184 H64F208  H640231 H640251 H640273 H64E164 H64F185 H64F209 H640232 H640252 H640275 H64E165  H64F189 H64F210 H640233 H640253  
Recalling Firm/
Manufacturer		 Varian Medical Systems
700 Harris Street
Suite 109
Charlottesville VA 22903-4584
For Additional Information Contact Varian BrachyTherapy
434-979-1540
Manufacturer Reason
for Recall		 Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. Erroneous data may be listed on the treatment history report, and the default step size may lead to a misadministration if treatment data is entered manually.
FDA Determined
Cause 2		 Other
Action The recalling firm notified end users by letter on 05/01/06 and advised users of possible communication error between afterloader devices and software. The notification also advised that the control program for the devices has the potential to lead to a misadministration of treatment in cases where data is manually entered by the user. The firm additionally advised that user may continue to use the afterloader devices if following the listed cautionary statements. A software upgrade is planned to be implemented at the user site''s next regularly scheduled radiation source exchange. A response form is enclosed with the notification and users are requested to return the customer receipt verification via fax.
Quantity in Commerce 254 total units
Distribution Nationwide and worldwide.
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 = JAQ and Original Applicant = GAMMAMED USA
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