International safety notice
The manufacturer has informed us about the operation of the collision detection system implemented in the system. -For PTS-8, PTS-10, and PTS-11 versions, users can deactivate collision detection for 20 seconds after detecting a collision to move the patient positioning system (PPS) out of a collision situation, but with collision detection temporarily deactivated. between the Patient Positioning System Control Unit (PPSCU) and the Positioning Control Unit (PCU), even when activated. If a communication failure occurs in the PPS operation is not allowed for 20 seconds because the disable request is not processed correctly. -In the PTS-12 version, the system indicates to the user that collision detection will be automatically deactivated during the next motion. notify the user. However, it is necessary to make it widely known. We check the instructions from the manufacturer, provide information to users, and install software for the target equipment. We will carry out voluntary renovations of software, etc. (PTS-10) and training, etc. (PTS-12).
Japan / PMDA Recalls · JPN · Jul 22, 2024
Key facts
| Title | The manufacturer has informed us about the operation of the collision detection system implemented in the system. -For PTS-8, PTS-10, and PTS-11 versions, users can deactivate collision detection for 20 seconds after detecting a collision to move the patient positioning system (PPS) out of a collision situation, but with collision detection temporarily deactivated. between the Patient Positioning System Control Unit (PPSCU) and the Positioning Control Unit (PCU), even when activated. If a communication failure occurs in the PPS operation is not allowed for 20 seconds because the disable request is not processed correctly. -In the PTS-12 version, the system indicates to the user that collision detection will be automatically deactivated during the next motion. notify the user. However, it is necessary to make it widely known. We check the instructions from the manufacturer, provide information to users, and install software for the target equipment. We will carry out voluntary renovations of software, etc. (PTS-10) and training, etc. (PTS-12). |
|---|---|
| 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