Reported Mar 30, 2016 · Terminated
MHI-TM2000 Linear Accelerator System (Software Version 3.0.0 and after) Intended for radiation therapy of lesions,…
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 and after) Intended for radiation therapy of lesions, tumors. conditions anywhere in the body where radiation therapy is indicated.
- Lot codes and dates
- Serial numbers
201901201902201903201904201905202901202902202903202904202905202906203901203902203903203904203905203906203918203919203921203922203924203925203927 and 203929
- Serial numbers
- Amount recalled
- 25 devices (4 domestically in U.S.A. and 21 internationally)
Where it was sold
Why it was recalled
Due to Operator Console software anomaly, a change in treatment completion status of the last patient of the day may be altered from "Completed (or Discontinued)" to "Untreated" under specific conditions.
This product could cause temporary or reversible health problems — stop using it.
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