fda
2 records
FDA Device Recall: MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intende
2016-03-30
Class II — Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under speci...
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FDA Device Recall: MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
2015-05-13
Class II — The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treat...
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