Device product
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
Z-1574-2015
Product summary
- Event
- Event 70638
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11 units total
- Official record key
device-enforcement:Z-1574-2015
Official wording
Reason: 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 treatment record (the delivered radiation record) cannot be saved.
Code information: Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919 & 203924
Distribution pattern: Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
Derived failure modes
-
Unknown
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 treatment record (the delivered radiation record) cannot be saved.