Devices

Device Recall ARTISTE MV System

  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    United States distribution
  • 제품 설명
    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.
  • Manufacturer
    Siemens Medical Solutions USA, Inc
  • 1 Event

제조사

Siemens Medical Solutions USA, Inc
  • 제조사 주소
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • 제조사 모회사 (2017)
    Siemens Ag
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

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Device Recall ARTISTE MV System, LInear Accelerator (LINAC)
  • 모델명 / 제조번호(시리얼번호)
    Model number: 08139789, serial numbers: 5419,  5784,  5830
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to the states of UT, WI, and NY.
  • 제품 설명
    ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. || The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
  • Manufacturer
    Siemens Medical Solutions USA, Inc
Device Recall ARTISTE MV System
  • 모델명 / 제조번호(시리얼번호)
    Device Model# 8139789
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed throughout the United States
  • 제품 설명
    ARTISTE" MV System
  • Manufacturer
    Siemens Medical Solutions USA, Inc
Device Recall Artiste MV system
  • 모델명 / 제조번호(시리얼번호)
    All products with COHERENCE Therapist RTT4.1
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide in LA, WI, DE, PA and OH, and internationally in Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium and France
  • 제품 설명
    Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement.
  • Manufacturer
    Siemens Medical Solutions USA, Inc