Z-1308-2016 Class II Terminated
FDA device recall Z-1308-2016 was initiated by MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK on March 7, 2016 and is designated Class II. 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 be… The recall status is terminated (terminated April 20, 2017). Affected quantity: 25 Worldwide, US: 4 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 6, 2016
- Initiation Date
- March 7, 2016
- Termination Date
- April 20, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25 Worldwide, US: 4 units
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution including New York, Texas, Florida, and Ohio
Code Information
Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924