Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5 Recalled by Siemens Medical Solutions USA, Inc Due to Siemen's issued a Customer Information Letter under Update...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Medical Solutions USA, Inc directly.
Affected Products
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 of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Quantity: 621 units (foreign account) in total
Why Was This Recalled?
Siemen's issued a Customer Information Letter under Update Instruction TH016/12S to alert all its affected customers of the software issues. The software release is a result of the final system testing addressing multiple performance defects and several safety issues that were not considered critical (for immediate correction) for the safe use of the device.
Where Was This Sold?
Worldwide Distribution
About Siemens Medical Solutions USA, Inc
Siemens Medical Solutions USA, Inc has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report