Recall Z-1308-2016 ยท IYE Accelerator, Linear, Medical
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
| Date | Mar 31, 2016 (initiated Mar 7, 2016) |
| Status | Terminated |
| Reason | In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met. If Gantry angle for the first beam of IMRT is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient. |
| Root cause | Software design |
| Action | A Field Safety Notice dated March 2, 2016, was sent to all affected customers via e-mail on March 7, 2016. The Field Safety Notice informed users of the problem and provided a safe workaround until corrected software is available. The correction will be free of charge and a Customer Service Representative will contact all affected customers to schedule its installation. Customers with questions were advised to contact their Customer Service Representative. |
| Quantity | 25 Worldwide, US: 4 units |
| Distribution | Nationwide Distribution including New York, Texas, Florida, and Ohio |
| FDA record | Open on fda.gov |