MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK: Medical Device Recall in 2014 - (Recall #: Z-0821-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.

Product Classification:

Class II

Date Initiated: December 2, 2014

Date Posted: December 24, 2014

Recall Number: Z-0821-2015

Event ID: 69825

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

Status: Terminated

Product Quantity: Domestic: 4 units

Code Information:

Serial Numbers: 201902, 203901, 203919, and 203924 (US only)

Distribution Pattern:

US Distribution to the states of NY, FL, TX and OH.

Voluntary or Mandated:

Voluntary: Firm initiated