VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM200...

FDA Device Recall #Z-1308-2016 — Class II — March 7, 2016

Recall Summary

Recall Number Z-1308-2016
Classification Class II — Moderate risk
Date Initiated March 7, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Location HIROSHIMA, N/A
Product Type Devices
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

Lot / Code Information

Software version 3.5.8, 3.5.2 and lower; Serial Numbers: 201902, 203901, 203919, 203924

Other Recalls from MITSUBISHI HEAVY INDUSTRIES, LTD., HI...

Recall # Classification Product Date
Z-1244-2016 Class II MHI-TM2000 Linear Accelerator System (Software ... Dec 15, 2015
Z-1574-2015 Class II MHI-TM2000 Linear Accelerator System (Software ... Apr 17, 2015
Z-0821-2015 Class II VERO Linear Accelerator System, Model Number MH... Dec 2, 2014
Z-2653-2014 Class II VERO Linear Accelerator System, Model Number M... Jul 5, 2014
Z-1931-2013 Class II MHI-TM2000 Linear Accelerator System, Software ... Jun 21, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.