Siemens Medical Solutions USA, Inc Siemens, Oncor Impression Plus, Part No.: 58 57 912, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens, Oncor Impression Plus, Part No.: 58 57 912, Medical Charge particle radiation therapy system,with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Model number 5857912
Products Sold
Model number 5857912, Serial Numbers 3739 3753 3761 3764 3769 3776 3783 3791 3793 3796 3799 3801 3802 3808 3827 3841 3846 3848 3858 3865 3877 3901 3945 3948 3953 3954 3955 3957 3964 3965 3975 3981 3983 3989 3998 4002 4005 4008 4009 4011 4015 4017 4019 4022 4027 4035 4053 4065 4067 4068 4072 4074 4084 4091 4096 5004 70-4097 70-4107 70-4119 70-4122 70-4123 70-4124 70-4127 70-4129 70-4132 70-4135 70-4136 70-4137 70-4142 70-4144 70-4145 70-4147 70-4149 70-4153 70-4154 70-4157 70-4158 70-4159 70-4161 70-4166 70-4171 70-4172 70-4174 70-4175 70-4176 70-4177 70-4183 70-4209 70-4215 70-4222 70-4224 70-4231 70-4241 70-4244 70-4253 70-4258 70-4262 70-4272 70-4278 70-4288 70-4295 70-4299 70-4301 70-4305 70-4306 70-4312 70-4317 70-4328 70-4329 70-4334 70-4335 70-4343 70-4345 70-4346 70-4348 70-4349 70-4356
Siemens Medical Solutions USA, Inc is recalling Siemens, Oncor Impression Plus, Part No.: 58 57 912, Medical Charge particle radiation therapy syste due to Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.
Recommended Action
Per FDA guidance
The firm has issued a Customer Safety Advisory Notice dated 12/6/2006, to all sites that have the pre-R2.0 OPTIVUE Flat Panel Positioners installed. Users will have a new microswitch-based collision detection system, installed free of charge.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AR, CA, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MT, NE, NV, NJ, NY, NC, ND, OH, OK, PA, SC, SD, TN, TX, WV, WI, WY
Page updated: Jan 10, 2026