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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1308-2016
Related Recalls
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.
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
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.
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record) cannot be saved.
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a Digitally Reconstructed Radiograph (DRR) image taken from the angle for the 1st port image fusion, rather than the one taken from the angle for the intended port