Siemens Medical Solutions Recalls RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling RT Therapist software versions 4.2.108 to fix multiple safety-related issues on linear accelerator systems.
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 is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The source text does not report specific injuries or deaths, placing it in the High severity category per the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling the RT Therapist RTT 4.2.108 and RT Therapist Connect RTT 4.2.108 software. This software is used on Siemens ARTISTE, ONCOR, and PRIMUS linear accelerator systems, which deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
The recall is a Class II recall initiated to fix multiple safety-related issues identified in the software. The affected software versions are Syngo RT Therapist RTT 4.2.108 (part number 8162815) and Syngo ST Theratpist Connect RTT 4.2.108 (part number 8168754).
Approximately 245 active devices are affected by this recall. The products were distributed nationwide in the United States and internationally to numerous countries including Poland, India, Canada, Germany, and the United Kingdom. Customers using these specific software versions on the affected linear accelerator systems should contact Siemens Medical Solutions for a software update.
The recalled product
- Product
- Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation fo
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 245
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 (3)
- Syngo RT Therapist RTT 4.2.108
- part number 8162815: Syngo ST Theratpist Connect RTT 4.2.108
- part number 8168754
Distribution
Distributed nationwide across the United States.
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