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Terminated

PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.

FDA Recall Z-1892-2019 · Posted None

Recalling FirmHitachi America, Ltd., Power Systems Division
Recall StatusTerminated
Product CodeLHN
Date Initiated2019-04-15
Date Terminated2020-04-24
Product Quantity3

Reason for Recall

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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