Recall Z-1574-2015 ยท IYE Accelerator, Linear, Medical
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
| Date | May 1, 2015 (initiated Apr 17, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Software design (manufacturing process) |
| Action | 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 |
| Quantity | 11 units total |
| Distribution | Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany. |
| FDA record | Open on fda.gov |