Device Recall Syngo Based WS for 3rd party V&R;

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 - Syngo Based WS for 3rd party V&R; equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 7345437. 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.