VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Vers...
FDA Recall #Z-0821-2015 — Class II — December 2, 2014
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
Recalling Firm
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK — HIROSHIMA, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
Domestic: 4 units
Distribution
US Distribution to the states of NY, FL, TX and OH.
Code Information
Serial Numbers: 201902, 203901, 203919, and 203924 (US only)
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated