Device Recall Coherence Therapist System

Manufacturer

  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial Numbers: 10007, 10010, 10015, 10017, 10020, 10026, 10028, 10030, 10037, 10038, 10001, 10003, 10004, 10005, 10008, 10009, 10011, 10019, 10027, 10031, 10039, 11004, 11006, 10006, 10018 ,10021, 10022, 10024, 10025, 11005, 10016, 10023, 10029, 10032, 10033, 10035, 10036, 10040, 11001, and 11008.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.
  • Product Description
    Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.
  • Manufacturer
  • Model / Serial
    Serial numbers associated with RTT2.0 and RTT2.1
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Coherence Therapist System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8147667 || Medical charged-particle radiation therapy system.
  • Manufacturer
  • Model / Serial
    Medical Linear accelerators equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1  Software Numbers 8146503, 8149119, and 8163318. Applies only to those parts used with the following devices identified in the product descriptions.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Product distribution information pending from firm.
  • Product Description
    Radiation therapy system - Coherence Therapist System 2.1 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147667. Medical charged particle Radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO standard medical imaging platform to provide comprehensive oncology workflow solutions for radiation therapy.
  • Manufacturer