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

FDA device recall Z-0821-2015 · posted 2014-12-17 · Terminated

Recall details

Recalling firm

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

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

Action taken

Mitsubishi sent a Field Safety Notice dated November 14, 2014, that was e-mailed to US end users on December 2, 2014, which provided actions to be taken by the end users. If users need any further information or support concerning this issue, they may contact MHI's Customer Service Representative, Brainlab AG in Germany, contact person: Franz Gum, Tel: +49-89-99-1568-0, Fax: +49-89-99-1568-33, E-mail: Franz.Gum@brainlab.com. If any other abnormality is detected, stop operation and contact MHI's Customer Service representative immediately. --- An Updated Field Safety Notice (dated December 4, 2014,) was sent to end users to correct some terms used in the initial notification.

Root cause

Software design

Status

Terminated

Product code

IYE

Quantity affected

Domestic: 4 units

Distribution

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

Date initiated

2014-12-02

Date posted

2014-12-17

Date terminated

2017-06-26

Location

HIROSHIMA, 4-CHOME KAN-ON-SHIN-MACHI, Japan

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