|
Class 2 Device Recall HITACHI PROBEATV |
|
Date Initiated by Firm |
April 15, 2019 |
Create Date |
June 28, 2019 |
Recall Status1 |
Terminated 3 on April 24, 2020 |
Recall Number |
Z-1892-2019 |
Recall Event ID |
83056 |
510(K)Number |
K152592 K151132
|
Product Classification |
System, radiation therapy, charged-particle, medical - Product Code LHN
|
Product |
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system. |
Code Information |
2015B01, A01, A02 |
Recalling Firm/ Manufacturer |
Hitachi America, Ltd., Power Systems Division 1840 Old Spanish Trl Houston TX 77054-2002
|
For Additional Information Contact |
Akinori 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 |
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 in Commerce |
3 |
Distribution |
Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan. |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = LHN and Original Applicant = Hitachi, Ltd.,Health Care Company
|
|
|
|