Devices

Device Recall Coherence Therapist 2.0

  • Model / Serial
    Serial Numbers: 10035, 10037, 15901, 10020, 10030, 10034, 10002
  • Product Classification
    Radiology Devices
  • 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 2.0 medical charged-particle radiation therapy system, Part No: 8139839, with software version 2.1. Siemens AG, Concord, CA.
  • Manufacturer
    Siemens Medical Solutions USA, Inc
  • 1 Event

Manufacturer

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

2 devices with a similar name

Learn more about the data here

Device Recall Coherence Therapist 2.0
  • Model / Serial
    Serial numbers associated with RTT2.0 and RTT2.1
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Coherence Therapist 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139839 || Medical charged-particle radiation therapy system.
  • Manufacturer
    Siemens Medical Solutions USA, Inc
Device Recall Coherence Therapist 2.0
  • 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
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Product distribution information pending from firm.
  • Product Description
    Radiation therapy system - Coherence Therapist 2.0 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139839. 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
    Siemens Medical Solutions USA, Inc