CLASS II Device recall · Reported 6 Apr 2016 · FDA Enforcement Report
Medical Linear Accelerator MHI-TM2000 Linear Accelerator recalled
Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work is recalling Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation, distributed nationwide in the US. The recall was initiated on 7 Mar 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1308-2016
- FDA event ID
- 73436
- Recalling firm
- Mitsubishi Heavy Industries, Ltd., Hiroshima Machinery Work, HIROSHIMA, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Mar 2016
- FDA classified
- 31 Mar 2016
- Reported
- 6 Apr 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Mar 2016 | Recall initiated by company | |
| 31 Mar 2016 | Classified by FDA | +24 days |
| 6 Apr 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical 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.
Where it was distributed
Nationwide Distribution including New York, Texas, Florida, and Ohio
Questions about this recall
Why was it 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.
Which lots are affected?
Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924
Where was it sold?
Nationwide Distribution including New York, Texas, Florida, and Ohio
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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