Siemens Syngo RT Therapist Software Recalled for Safety Issues
Siemens Medical Solutions is recalling Syngo RT Therapist software to address several safety issues. The recall affects 103 linear accelerators nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software with unspecified safety issues and no reported injuries, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the Syngo RT Therapist software application. This software is used for viewing, processing, and archiving medical images, as well as for patient data management, treatment planning, and treatment delivery verification on linear accelerators.
The recall is being conducted to install a software patch that addresses several safety issues. The source text does not specify the exact nature of these safety issues or report any specific injuries or illnesses.
The recall affects 103 linear accelerators distributed nationwide. Affected units are identified by Model # 08162815, 8168754 and specific serial numbers listed in the agency record. Users of this software should contact Siemens Medical Solutions USA, Inc. for information regarding the installation of the required software patch.
The recalled product
- Product
- 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 positionin
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 103
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model # 08162815
- 8168754 Serial # 10019
- 10626
- 10651
- 10672.10678
- 10702
- 10703
- 10706
- 10712
- 10758
- 10767
- 10804
- 10625
- 10063
- 10770
- 10831
- 10008
- 10786
- 10789
- 10756
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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