Device product
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
Z-0821-2015
Product summary
- Event
- Event 69825
- Status
- Terminated
- Classification
- Class II
- Quantity
- Domestic: 4 units
- Official record key
device-enforcement:Z-0821-2015
Official wording
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
Code information: Serial Numbers: 201902, 203901, 203919, and 203924 (US only)
Distribution pattern: US Distribution to the states of NY, FL, TX and OH.
Derived failure modes
-
Device software or design
Software Anomaly