03
Aug
2006

Class II Varian Medical Systems

0

Company: Varian Medical Systems,
Date of Enforcement Report:8/2/2006
Class:lI

PRODUCT
a) Gamma Win software, part number GM11019110, versions up to and
including 1.62, for the GammaMedplus radionuclide applicator system,
for radiation therapy, Recall # Z-1268-06;
b) Gamma Win software, part number GM11019110, versions up to and
including 1.62, for the GammaMedplus 3/24 radionuclide applicator system,
for radiation therapy, Recall # Z-1269-06;
c) Gamma Win software, part number GM11019110, versions up to and
including 1.62, for the Mammo Source radionuclide applicator system,
for radiation therapy, Recall # Z-1270-06

REASON
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.

CODE
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;
b) 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;
c) 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
H640238H640258 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
Recalling Firm: Varian Medical Systems, Charlottesville, VA, by letter on May 1, 2006.
Manufacturer: Varian Medical Systems, Haan, Germany. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
254 units

DISTRIBUTION
Nationwide and Internationally

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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