Siemens Medical Solutions Recalls COHERENCE RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions for Primus and Oncor linear accelerators to address performance defects and safety issues.
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 3/5 (High).
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 involves a medical device used for cancer treatment with identified safety issues, but the source explicitly states these issues were not considered critical for immediate correction and no injuries are reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
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 accelerator systems, which are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
The recall is being conducted to address multiple performance defects and several safety issues identified during final system testing. The manufacturer 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.
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 AG TH, Part No. 5863506, 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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