January 19, 2022
Company: Ion Beam Applications S.A. Date of Enforcement Report: 1/19/2022 Class II PRODUCT Proteus 235; Version: PTS-8 versions before PTS-8.7.2 Recall Number: Z-0466-2022 REASON Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the...
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 1/19/2022 Class II PRODUCT SOMATOM Confidence – Computed tomography systems Model: 10590100 Recall Number: Z-0472-2022 SOMATOM Definition AS-Computed tomography system Model 8098027 Recall Number: Z-0473-2022 SOMATOM Edge Plus-Computed tomography system Model 1026700 Recall Number: Z-0474-2022 SOMATOM Definition Edge -Computed tomography system Model 10590000 Recall Number:...
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