Recall Z-1244-2016 ยท IYE Accelerator, Linear, Medical
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
| Date | Mar 24, 2016 (initiated Dec 15, 2015) |
| Status | Terminated |
| Reason | 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 specific conditions. |
| Root cause | Software design |
| Action | 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" if all the following conditions are met: (1) At least one patient has been treated on the day; (2) A major error occurs when VeroTM/MHI-TM2000 is operated in a mode, other than Clinical Mode, which means Daily Check Mode or Maintenance Mode. (3) The major error is NOT associated with a function that uses therapeutic/ MV radiation parameters, such as an error in Isocenter Check function, etc. Note 1: If the major erro |
| Quantity | 25 devices (4 domestically in U.S.A. and 21 internationally) |
| Distribution | Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium. |
| FDA record | Open on fda.gov |