Recall Z-1585-2018 ยท IYE Accelerator, Linear, Medical
Hitachi Ltd., Medical System Operations Group
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.
| Date | Dec 8, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Hitachi sent a Field Safety Notice letter dated November 28, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The notification letter includes instructions for the user on how to verify patient position even with the software issue. The letter also explains that correction software is being developed with a tentative release date of, "End of January, 2018.". A customer service representative will contact affected customers about installing the software. For questions contact your our Customer Service Representative. |
| Quantity | 1 |
| Distribution | US Distribution in the state of NY. |
| FDA record | Open on fda.gov |