Z-1585-2018Class II

MHI-TM2000 Linear Accelerator System

Name: Z-1585-2018 MHI-TM2000 Linear Accelerator System
Creator: Hitachi Ltd., Medical System Operations Group
Published: 2017-12-08
License: https://open.fda.gov/license/

FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa / initiated 2017-12-08 / Terminated / root cause: design

FDA source

Hitachi Ltd., Medical System Operations Group began a recall of MHI-TM2000 Linear Accelerator System Product Usage: MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions... on 2017-12-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1585-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-08
Posted: 2018-05-01
Terminated: 2019-04-11
Recalling firm: FUJIFILM Corporation Medical Systems Research & Development Center Kashiwa
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Hitachi sent a Field Safety Notice letter dated November 28, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The notification letter includes instructions for the user on how to verify patient position even with the software issue. The letter also explains that correction software is being developed with a tentative release date of, "End of January, 2018.". A customer service representative will contact affected customers about installing the software. For questions contact your our Customer Service Representative.
Quantity in commerce: 1
Distribution: US Distribution in the state of NY.
Product codes and lots: Serial Number: 203919

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1585-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1585-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-09	2018-05-01

Product code IYE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)