Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1244-2016 — 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.

U.S. FDA — Device Enforcement · Japan · 2015-12-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1244-2016
Date of alert: 2015-12-15
Country / jurisdiction: Japan
Risk level: Class II
Risk type: recall
Brand: MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-1244-2016 — 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.

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