Company: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK.
Date of Enforcement Report 12/24/2014
Class lI:
PRODUCT
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
Recall Number Z-0821-2015
REASON
Software Anomaly; Because of a software bug, 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/MANUFACTURER
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK, Hiroshima, JP on 12/2/14. Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
US Distribution to the states of NY, FL, TX and OH.
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