MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
This recall has been terminated (originally issued May 1, 2015).
- Recall Initiated
- April 17, 2015
- Posted
- May 1, 2015
- Terminated
- April 11, 2017
- Recall Number
- Z-1574-2015
- Quantity
- 11 units total
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
Lot / Code Info
Serial Numbers: 201902, 201903, 202903, 202905, 203901, 203902, 203903, 203905, 203906, 203919 & 203924
Root Cause
Software design (manufacturing process)
Action Taken
MITSUBISHI HEAVY INDUSTRIES, LTD. has issued a Safety Alert for the MHI-TM2000 Linear Accelerator System dated April 10, 2015, due to a software issue. Customers were advised not to deliver therapeutic X-ray if popup warning message show is displayed during treatment. Instructions were provided if therapeutic radiation is delivered during popup warning. Customers with questions should contact the Customer Service Representative by calling 1-800-597-5911, Monday through Friday or email: us.support@brainlab.com. **CAPA** Correction software for this issue has a tentative availability date of June 2015. Estimated software update completion date would be end of October 2015.