Recall Z-1931-2013 ยท IYE Accelerator, Linear, Medical
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name: MHI-TM2000/ VERO (TM); 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 | Aug 8, 2013 (initiated Jun 21, 2013) |
| Status | Terminated |
| Reason | Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain conditions. |
| Root cause | Software Design Change |
| Action | The firm, Mitsubishi Heavy Industries, Ltd. (MHI), sent an "URGENT FIELD SAFETY NOTICE" letter dated June 21, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: If any minor failure occurs, please always press [ALARM RESET] button on operator console first; and if [EXIT] button is clicked after a minor failure occurs, please click [YES] on the pop up dialog to finish treatment completely. MHI is developing a correction for this issue. Tentatively planned availability date: End of October 2013. The correc |
| Quantity | 14 (2 in US) |
| Distribution | Worldwide distribution: US (nationwide) including states of TX and FL; and countries of: Belgium, Italy, Japan and Korea. |
| FDA record | Open on fda.gov |