Recall Z-1041-2013 — 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 brand
U.S. FDA — Device Enforcement · United States · 2013-03-05 · Class II
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Reported risk: 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.
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