Siemens Medical Solutions USA, Inc: Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.

Agency Publication Date: February 16, 2017

Affected Products

Product: ARTISTE MV System, 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.

Model Number: 8139789 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

Product: ONCOR Avant-garde, 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.

Model Number: 5863472, 5857920 and 5857912 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

Product: 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.

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

Product: PRIMUS 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.

Model Number: 1940035 and 4504200 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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76454

Status: Resolved

Manufacturer: Siemens Medical Solutions USA, Inc

Manufactured In: United States

Units Affected: 4 products (194 systems)

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Sources: FDA iRES · Raw API Response

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Affected Products