Siemens COHERENCE RT Therapist Software Recall for Safety Defects
Siemens is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states the safety issues were not considered critical for immediate correction, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling specific versions of the COHERENCE RT Therapist software, including RTT MR1.5, RTT 2.1/2.1A, and RTT 2.2/2.2B, as well as the software release for COHERENCE Therapist 2.3. These software components are used with Primus and Oncor linear accelerators, which are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
The recall was initiated to address multiple performance defects and several safety issues identified during final system testing. Siemens issued a Customer Information Letter under Update Instruction TH016/12S to alert affected customers. The company noted that these safety issues were not considered critical for immediate correction for the safe use of the device.
A total of 621 units were distributed worldwide. Affected customers should refer to the Customer Information Letter for specific instructions on updating the software to resolve the identified defects.
The recalled product
- Product
- SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE TH, Part No. 7339125, - Current R630; Product Usage: The intended use of
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 621
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 (1)
- All units of these models.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 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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