Recall Z-1892-2019 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
Hitachi America, Ltd., Power Systems Division
PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.
| Date | Apr 15, 2019 |
| Status | Terminated |
| 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 befor |
| Quantity | 3 |
| Distribution | Distributed to accounts located in AZ, MN, and TN. Foreign distribution to Japan. |
| FDA record | Open on fda.gov |