FDAFDA · Food and drugs·Recall number Z-2653-2014
VERO Linear Accelerator System, Model Number MHI-TM2000; 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.
Published September 24, 2014 · Recall initiated: July 5, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
- Distributor
- Distributed in the states of NY, FL, and TX.
- Lot
- Software Version 3.0.0 and after. Serial Numbers 201902, 203901, and 203919
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Japan
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