PlainRecalls
FDA Devices Moderate Class II Terminated

Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording

Reported: October 5, 2016 Initiated: July 26, 2016 #Z-2878-2016

Product Description

Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording

Reason for Recall

Software patch installation to address several safety issues.

Details

Units Affected
103 accelerators
Distribution
Nationwide distribution
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 103 accelerators.
Why was this product recalled?
Software patch installation to address several safety issues.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 5, 2016. Severity: Moderate. Recall number: Z-2878-2016.