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Recall Observatory FDA recall evidence

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

December 02, 2014

Class II

Product summary

Firm
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
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

    reason.device_software_design · v1.0.0

    Software Anomaly