FDA Recall 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

Recall: Z-2878-2016 · Initiated July 26, 2016

Recall

Recall Number
Z-2878-2016
Event Number
75113
Firm
Siemens Medical Solutions USA, Inc
FEI Number
2240869
Product Code
IYE
Status
Terminated
Root Cause
Software design
Initiated
July 26, 2016
Terminated
May 10, 2018
Address
40 Liberty Blvd, Malvern, PA, 19355-1418

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

Software patch installation to address several safety issues.

Action

Siemens sent a Field Safety Notice to all affected customers informing them of a new software patch that they plan to install to address software issues. Customers were advised to notify anyone at their organization who should be aware of the information contained in the Notice. Customers were also advised to include the Field Safety Notice in their System Owner Manual, chapter "Safety Advisory Letters" where it should remain. For questions regarding this recall call 610-219-4834.

Distribution

Nationwide distribution

Quantity

103 accelerators