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.
FDA Recall Z-1308-2016 · Posted 2016-03-31
Recall StatusTerminated
Product CodeIYE
Date Initiated2016-03-07
Date Terminated2017-04-20
Product Quantity25 Worldwide, US: 4 units
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.
Firm Action
A Field Safety Notice dated March 2, 2016, was sent to all affected customers via e-mail on March 7, 2016. The Field Safety Notice informed users of the problem and provided a safe workaround until corrected software is available. The correction will be free of charge and a Customer Service Representative will contact all affected customers to schedule its installation. Customers with questions were advised to contact their Customer Service Representative.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution including New York, Texas, Florida, and Ohio
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.