Siemens COHERENCE RT Therapist Software Recalled for Performance Defects
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical 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 source text explicitly states that the safety issues were not considered critical for immediate correction, and no injuries or illnesses are reported, fitting the criteria for a voluntary precautionary recall or low-risk issue.
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 used with Primus and Oncor Linear Accelerators. The affected model is COHERENCE TH 2.0, Part No. 8139839, Current R630. These devices 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. The source text explicitly states that these safety 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 instructions regarding the software update.
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 2.0, Part No. 8139839, 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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