Recall Z-0821-2015 ยท IYE Accelerator, Linear, Medical
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
| Date | Dec 17, 2014 (initiated Dec 2, 2014) |
| Status | Terminated |
| Reason | Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a Digitally Reconstructed Radiograph (DRR) image taken from the angle for the 1st port image fusion, rather than the one taken from the angle for the intended port |
| Root cause | Software design |
| Action | Mitsubishi sent a Field Safety Notice dated November 14, 2014, that was e-mailed to US end users on December 2, 2014, which provided actions to be taken by the end users. If users need any further information or support concerning this issue, they may contact MHI's Customer Service Representative, Brainlab AG in Germany, contact person: Franz Gum, Tel: +49-89-99-1568-0, Fax: +49-89-99-1568-33, E-mail: Franz.Gum@brainlab.com. If any other abnormality is detected, stop operation and contact MHI's Customer Service representative immediately. --- An Updated Field Safety Notice (dated December |
| Quantity | Domestic: 4 units |
| Distribution | US Distribution to the states of NY, FL, TX and OH. |
| FDA record | Open on fda.gov |