International safety notice
Communication from the manufacturer confirms safety parameters tested by the Beam Access Point Process (BAPP) in clinical practice. It has been found that irradiation cannot be prevented even when the configuration of the equipment is outside the acceptable range. The safety parameter validation mechanism within the PP was found to be malfunctioning. We check the instructions from the manufacturer, provide information to users, and install software for the target equipment. We will carry out voluntary repairs to software, etc.
Japan / PMDA Recalls · JPN · Apr 18, 2024
Key facts
| Title | Communication from the manufacturer confirms safety parameters tested by the Beam Access Point Process (BAPP) in clinical practice. It has been found that irradiation cannot be prevented even when the configuration of the equipment is outside the acceptable range. The safety parameter validation mechanism within the PP was found to be malfunctioning. We check the instructions from the manufacturer, provide information to users, and install software for the target equipment. We will carry out voluntary repairs to software, etc. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Particle therapy device Brand name: Proton beam therapy device ProteusONE |
| Manufacturer | IBA Japan Co., Ltd. |
| Models | SBF104, SBF103 |
| Date | Apr 18, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1