Reported Aug 14, 2013 · Terminated
MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier; Proprietary and Trade Name:…
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?
- MHI-TM2000 Linear Accelerator System, Software Version 3.0.0 revision 13 or earlier
- Proprietary and Trade NameMHI-TM2000/ VERO (TM)
- Common NameMedical Linear Accelerator. MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated
- Lot codes and dates
- Serial Numbers #s 201902 and 203901
- Amount recalled
- 14 (2 in US)
Where it was sold
Why it was recalled
Software anomaly: Mitsubishi Heavy Industries, Ltd. became aware of a potential safety issue associated with the VERO (TM) Linear Accelerator System. The VERO (TM) may save treatment delivery record into wrong location under certain conditions.
This product could cause temporary or reversible health problems — stop using it.
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