Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and no injuries or illnesses are reported, 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 for Primus and Oncor Linear Accelerators. The affected model is COHERENCE TH 2.2, Part No. 10568431, Current R640. 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 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 and resolution of 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 2.2, Part No. 10568431, Current R640; Product Usage: The intended use…
- 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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