International safety notice
The safety parameter verification mechanism may be deactivated during some maintenance activities by communication from the manufacturer. We have identified certain configuration parameters that may be released as part of clinical configuration in some cases. did. 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 · Jul 22, 2024
Key facts
| Title | The safety parameter verification mechanism may be deactivated during some maintenance activities by communication from the manufacturer. We have identified certain configuration parameters that may be released as part of clinical configuration in some cases. did. 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 | Jul 22, 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