Device product
MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Z-1585-2018
Product summary
- Event
- Event 79439
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1585-2018
Official wording
Reason: Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
Code information: Serial Number: 203919
Distribution pattern: US Distribution in the state of NY.
Derived failure modes
-
Device software or design
software anomaly