Reported Sep 24, 2014 · Terminated
VERO Linear Accelerator System, Model Number MHI-TM2000; Common Name: Medical Linear Accelerator. MHI-TM2000 Linear…
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 System, Model Number MHI-TM2000
- 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 3.0.0 and after. Serial Numbers 201902, 203901, and 203919
- Amount recalled
- 3 units in use in the US
Where it was sold
Why it was recalled
Software Anomaly: If a user changes the calendar setting from Workday to Holiday or vice versa, that would erroneously change the status of treatment/fractions, which are completed and to become Treated (completed) status on the exact day when such change is made, to Untreated status. Furthermore, such treatment would be cloned and mistakenly added to the schedule as Untreated treatment
This product could cause temporary or reversible health problems — stop using it.
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