FDA Medical Device Recalls (openFDA)
Hitachi Ltd., Medical System Operations Group: 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
- Recalling firm
- Hitachi Ltd., Medical System Operations Group
- 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.
- Status
- Terminated
- Initiated
- 2017-12-08
- Posted
- not on file
- Terminated
- 2019-04-11
- 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.
- 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
- 1
- Distribution
- US Distribution in the state of NY.
- Lot, serial or model codes
- Serial Number: 203919
- 510(k) numbers
- ["K072047","K122450","K152867"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3018423337
- Firm city
- Kashiwa
- Firm state
- not on file
- Firm country
- Japan
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28