Reported Apr 6, 2016 · Terminated
VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator…
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 MHI-TM2000 Linear
- Accelerator System --- 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
Software version 3.5.83.5.2 and lower
- Serial Numbers
201902203901203919203924
- Amount recalled
- 25 Worldwide, US: 4 units
Where it was sold
Why it was recalled
In rare cases the VERO/MHI-TM2000 Operator Console could set an incorrect Gantry angle for the first beam of an IMRT treatment if certain specific conditions are met. If Gantry angle for the first beam of IMRT is incorrectly set and if nobody is aware of it, an erroneous treatment would be given to the patient.
This product could cause temporary or reversible health problems — stop using it.
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