Device Recall ONCOR Impression

Model Number: 5857920 Serial Numbers: 5377 3397 3986 5087 5093 70-4119 70-4144 70-4343 4078 5120 5170 5282 5506 70-4146 3855 5517 3422 3702 3751 3695 5364 3904 3781 5060 70-4316 5205 3383 3942 3981 4067 5157 5343 5844 3953 5148 5391 5300 3802 70-4143 70-4296 70-4235 5474 70-4363 70-4368 3791 3793 5833 5899 70-4378 3241 5355 3515 3574 3519 5281 5894 5374 5558 3225 3835 3367 3296 3591 3267 3679 3905 3922 3924 5367 3618 70-4354 70-4356 5540 3103 5488 3859 4019 5523 5350 5784 5821 70-4344 3979 3541 3413 3774 5843 3504 70-4129 5851 3354 3361 5098 3756 3305 3629 3136 5114 3748 5700 5410 70-4323 3666 3987 4036 3989 5865 3617 5118 5548 5861 5748 5222 3302 5737 5830 5245 5092 4021 5665 3815 5823 5088 3846 70-4178 70-4174 5353 70-4283 5630 70-4185 3639 3274 3761 5096 3801 3949 3878 3568 5572 3873 5417 5500 5388 70-4077 3547 5154 70-4287 70-4379 5226 3602 3657 3948 70-4135 3755 5601 5640 3622 5033 5177 3731 5707 5590 5657 70-4317 5398 4091 3644 4018 5532 70-4161 3114 3667 5424 3565 5755 5326 5525 5699 4082 70-4113 4015 5419 3998 3479 5481 5396 70-4347 4072 3939 5095 3901 5153 3244 5179

Radiology Devices

2

No

United States distribution

ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system || Product Usage: || The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.

Serial no: 3855 4019 4067 3953 5148 3793 5098 5222 3801 5388 3948 3755 5033 4015 5095

Radiology Devices

2

No

Worldwide Distribution- US Nationwide in the states: AL, CA, FL, GA, IL, IN, KY, MA, MI, MO, MS, NJ, NY, OH, OK, PA, RI, SC, TN, TX, WI, WV, and WY; and PR. International distribution to Nassau.

ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 || Product Usage: || The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.

MODEL NUMBER: 5857912: Serial Numbers: 3753, 3754, 3755, 3761, 3764, 3769, 3778, 3783, 3791, 3793, 3801, 3802, 3803, 3804, 3815, 3846, 3855, 3877, 3888, 3901, 3907, 3945, 3948, 3953, 3955, 3957, 3964, 3975, 3981, 3989, 3998, 4015, 4019, 4035, 4065, 4067, 4072, 4091, 5033, 5060, 5088, 5093, 5096, 70-4119, 70-4122, 70-4129, 70-4135, 70-4142, 70-4144, 70-4145, 70-4157, 70-4159, 70-4161, 70-4166, 70-4172, 70-4174, 70-4175, 70-4177, 70-4183, 70-4222, 70-4262, 70-4306, 70-4317, 70-4343, 70-4345, 70-4349, 70-4354, 70-4356, 70-4362, 70-4378, 70-4379, 3956, 4011, 70-4136, 70-4154, 70-4334, 4024, 3796, 3799, 3865,  70-4361, 3795, 4074, 5002, 5034, 5057, 3739, 3808, 4017, 4022, 4068, 4081, 4084, 4096, 5001, 5011, 5032, 5053, 5058, 5086, 5087, 5095, 70-4107, 70-4132, 70-4147, 70-4149, 70-4153, 70-4171, 70-4189, 70-4288, 70-4312, 70-4331, 70-4333, 70-4366, 5031, 70-4158, 3983, 3823, 3965, 5061, 5091, 70-4124, 70-4137, 70-4329, 70-4348, 5068, 5085, 70-4215, 70-4253, 70-4272, 70-4305, 70-4335, 70-4338, 70-4123, 70-4176, 70-4209, 3816, 4012, 4053, 5023, 70-4186, 70-4241, 70-4244, 3776, 3848, 3858, 3963, 4002, 4027, 70-4097, 70-4346, 70-4384, 4071, 3836, 3827, 4005, 5039, 5040, 70-4231, 5030, 70-4328, 70-4365, 4026, 70-4258, 70-4301, 4009, 3916, 70-4278, 3925, 3954, 5027, 5044, 5069, 70-4224, 70-4295, 70-4299, 5004, 704093, 3968, 4037, 70-4193, 70-4292, 70-4127, 3841, 3863, 4008, 4062, 4064.

Radiology Devices

2

No

Worldwide:USA including states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virgina, Wisconsin, and Wyoming and FOREIGN COUNTRIES: Canada, Mexico, Serbia Montenegro, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzeg-Bosnia, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, DPR of Korea, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uzbekistan, Venezuela, Vietnam, and Zambia

ONCOR IMPRESSION Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857912, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

MODEL NUMBER: 5857920 : Serial Numbers: 3878, 4021, 4078, 70-4143, 70-4207, 70-4235, 70-4257, 70-4344, 70-4296, 3974, 70-4165, 70-4167, 3729, 5022, 5035, 5074, 3811, 3845, 3962, 3973, 70-4152, 5015, 70-4238, 70-4374, 70-4386, 5024, 704083, 3894, 4048, 70-4276, 70-4277, 70-4281, 3883, 70-4083.

Radiology Devices

2

No

Worldwide:USA including states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Vermont, Virginia, Washington, West Virgina, Wisconsin, and Wyoming and FOREIGN COUNTRIES: Canada, Mexico, Serbia Montenegro, Angola, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzeg-Bosnia, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, DPR of Korea, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, Qatar, Rep. of Yemen, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Uzbekistan, Venezuela, Vietnam, and Zambia

ONCOR IMPRESSION,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5857920, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

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

Radiology Devices

2

No

Worldwide Distribution- USA including MA, ME, NJ, NY, PA, MD, WV, NC, SC, GA, FL, AL, TN, KY, OH, IN, MI, IA, WI, SD, ND, MT, IL, NE, LA, OK, TX, WY, NV, CA, AK AND AR, and countries of Serbia, Australia, Austria, Belgium, Canada, Denmark, El Salvador, France, Germany, Hungary, India, Ireland, Italy, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Norway, China, Philippines, Poland, Portugal, Qatar, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, Ukraine, UK.

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