Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Performance Defects
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and safety issues that were not considered critical for immediate correction.
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 source explicitly states that the safety issues were 'not considered critical (for immediate correction) for the safe use of the device,' which aligns with the rubric for voluntary precautionary recalls or low-risk issues (Score 2).
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 for Primus and Oncor Linear Accelerators. The affected models include the Primeview 3i 2.0, Part No. 8139847, Current R630. These devices are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
The recall was initiated after final system testing identified multiple performance defects and several safety issues. The source text notes that these issues were not considered critical for immediate correction for the safe use of the device. Siemens issued a Customer Information Letter under Update Instruction TH016/12S to alert affected customers of these software issues.
A total of 621 units were distributed worldwide. Affected customers should refer to the Customer Information Letter for specific guidance on addressing the software issues.
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: Primeview 3i 2.0, Part No. 8139847, Current R630; Product Usage: The intended us
- 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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