Reported Dec 24, 2014 · Terminated
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and…
Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK · 6-22, 4-CHOME, KAN-ON-SHIN-MACHI · HIROSHIMA, N/A · N/A
Is this the product you have?
VERO Linear Accelerator SystemModel Number MHI-TM2000MHI Identifier M101-14021
- Software Version
3.13.2 and 3.5.0
- Lot codes and dates
- Serial Numbers
201902203901203919and 203924 (US only)
- Serial Numbers
- Amount recalled
- Domestic: 4 units
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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