Device Recall Coherence Therapist System

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.

Radiology Devices

2

No

Worldwide Distribution-USA including 48 consignees in the US and 39 outside the US.

Siemens Coherence Therapist system, Part No: 7339125, medical charged-particle radiation therapy system with software version 2.1. Siemens AG, Concord, CA.

Serial numbers associated with RTT2.0 and RTT2.1

Radiology Devices

2

No

Worldwide Distribution

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.

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.

Radiology Devices

2

No

Class II Recall - Product distribution information pending from firm.

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.