09
May
2018

Hitachi MHI-TM2000 Linear Accelerator System Cl II

0

Company:Hitachi Ltd., Medical System Operations Group
Date of Enforcement Report 5/9/2018
Class lI:

PRODUCT

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.
Recall Number: Z-1585-2018

REASON
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.

RECALLING FIRM/MANUFACTURER
Hitachi Ltd., Medical System Operations Group, Kashiwa, Japanon 12/8/2017. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1

DISTRIBUTION
New York

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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