Z-0821-2015 Class II Terminated
FDA device recall Z-0821-2015 was initiated by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK on December 2, 2014 and is designated Class II. Reason for recall: 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. … The recall status is terminated (terminated June 26, 2017). Affected quantity: Domestic: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 24, 2014
- Initiation Date
- December 2, 2014
- Termination Date
- June 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 4 units
Product Description
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
Reason for Recall
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
Distribution Pattern
US Distribution to the states of NY, FL, TX and OH.
Code Information
Serial Numbers: 201902, 203901, 203919, and 203924 (US only)