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U.S. Department of Health and Human Services

Class 2 Device Recall HITACHI PROBEATV

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 Class 2 Device Recall HITACHI PROBEATVsee related information
Date Initiated by FirmApril 15, 2019
Create DateJune 28, 2019
Recall Status1 Terminated 3 on April 24, 2020
Recall NumberZ-1892-2019
Recall Event ID 83056
510(K)NumberK151132 K152592 
Product Classification System, radiation therapy, charged-particle, medical - Product Code LHN
ProductPROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
Code Information 2015B01, A01, A02
FEI Number 3003993895
Recalling Firm/
Manufacturer		 Hitachi America, Ltd., Power Systems Division
1840 Old Spanish Trl
Houston TX 77054-2002
For Additional Information ContactAkinori Okada
832-916-6098
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionThe 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 in Commerce3
DistributionDistributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = LHN
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