International safety notice
RayStation/RayPlan 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A incluidos algunos paquetes de servicio. Ver UDI- DI en la nota de aviso de la empresa.
Spain / AEMPS · ESP · Mar 18, 2024
Key facts
| Title | RayStation/RayPlan 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A incluidos algunos paquetes de servicio. Ver UDI- DI en la nota de aviso de la empresa. |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | RayStation/RayPlan 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A incluidos algunos paquetes de servicio. Ver UDI- DI en la nota de aviso de la empresa. |
| Manufacturer | RaySearch Laboratories AB, Suecia. |
| Models | ’12.1.1.41’, 0735000201048820220420, 12.1.4.113, 9.0.0.113, 0735000201017420190612, ‘8.1.1.8’, ’12.1.2.91’, 12.0.3.68, 12.3.0.119, ’12.1.3.162’, 13.1.1.89, ‘9.0.1.142’ and 91 more |
| Event type | Safety Notice |
| Date | Mar 18, 2024 |
At a glance
- No Recall
- Yes Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers in FDA data
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