Device product
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.
Z-1244-2016
Product summary
- Event
- Event 72991
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25 devices (4 domestically in U.S.A. and 21 internationally)
- Official record key
device-enforcement:Z-1244-2016
Official wording
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.
Code information: Serial numbers: 201901, 201902, 201903, 201904, 201905, 202901, 202902, 202903, 202904, 202905, 202906, 203901, 203902, 203903, 203904, 203905, 203906, 203918, 203919, 203921, 203922, 203924, 203925, 203927 and 203929.
Distribution pattern: Distributed in the states of Florida, New York, Ohio & Texas, and the countries of France, Germany, Japan, Italy, Korea, & Belgium.
Derived failure modes
-
Device software or design
software anomaly