FDA Medical Device Recalls (openFDA)
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha: Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
- Recall number
- Z-1430-2026
- Recalling firm
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Product
- Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
- Status
- Open, Classified
- Initiated
- 2026-02-06
- Posted
- 2026-02-20
- Terminated
- not on file
- Reason
- Software anomaly in the patient positioning system may result in positional discrepancy.
- Root cause
- Software design
- Action
- Between the dates of February 5-11, 2026, Hitachi, Ltd, issued an "URGENT: MEDICAL DEVICE RECALL" notification dated January 21, 2026, via Service Team Manager to affected consignees. Hitachi is asking consignees to take the following actions: 1. Until the PPS software has been updated with the corrected version, users are instructed to follow the System Operation instruction in the document. 2. Users are also asked to post the document in a prominent space and sign its cover. 3. Complete and return the acknowledgment and receipt form. Action by the firm: Hitachi plans to update the PPS software to a corrected version that prevents the mismatch between the commanded error correction parameter and the internal variable. starting in late March 2026 and the users will be contacted after the update. If you have any questions, please call QA Manager at Tel: (408) 986-6300. Monday through Friday, 8:00 AM to 5:00 PM, Central Time.
- Quantity
- 1 unit
- Distribution
- US distribution to states of: TX, Washington DC
- Lot, serial or model codes
- Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
- 510(k) numbers
- ["K191801","K201042"]
- PMA numbers
- not on file
- Product code
- LHN
- Firm FEI
- 1000162206
- 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