FDA Medical Device Recalls (openFDA)
Hitachi America, Ltd., Power Systems Division: PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
- Recall number
- Z-1892-2019
- Recalling firm
- Hitachi America, Ltd., Power Systems Division
- Product
- PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
- Status
- Terminated
- Initiated
- 2019-04-15
- Posted
- not on file
- Terminated
- 2020-04-24
- Reason
- There is a potential for a discrepant target position when using 3D3D matching mode in PIAS (Positioning Image Analysis System) software installed in the PROBEAT-V, proton therapy systems.
- Root cause
- Software design
- Action
- The firm informed affected user sites of the recall beginning on April 15, 2019, via an Engineering Document. The firm distributed updated Urgent Medical Device Recall letters in June 2019. The firm stated that the PIAS software would be replaced with the corrected version. Until the software was corrected, users were asked to take the following interim countermeasures: -Limit the number of treatment planning CT slices to odd numbers only. - Create treatment plan only in Head First condition for new patients. - Use the beam limiting device in full open in the lateral direction (same as before). Customers were asked to complete and return the customer response form to the firm. The firm stated that the software correction will be implemented from June 17 - 29, 2019.
- Quantity
- 3
- Distribution
- Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.
- Lot, serial or model codes
- 2015B01, A01, A02
- 510(k) numbers
- ["K151132","K152592"]
- PMA numbers
- not on file
- Product code
- LHN
- Firm FEI
- 3003993895
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
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