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

Recall Z-1585-2018 — MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

U.S. FDA — Device Enforcement · Japan · 2017-12-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1585-2018
Date of alert: 2017-12-08
Country / jurisdiction: Japan
Risk level: Class II
Risk type: recall
Brand: Hitachi Ltd., Medical System Operations Group
Product category: device
Product type: Devices

Reported risk: Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.

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

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Recall Z-1585-2018 — MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

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