International safety notice
Alert 2521 (Technosurveillance): Update - Siemens - Primus Digital Linear Accelerator and Oncor Linear Accelerator Software update in order to minimize the possibility of collision of the gantry or treatment table.
Brazil / Anvisa · BRA · Mar 16, 2018
Key facts
| Title | Alert 2521 (Technosurveillance): Update - Siemens - Primus Digital Linear Accelerator and Oncor Linear Accelerator Software update in order to minimize the possibility of collision of the gantry or treatment table. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Primus Digital Linear Accelerator and Oncor linear accelerator Technical name: Linear accelerator ANVISA registration number: 10234230073; Risk class: III Affected model: List of affected serial numbers (updated): 3221; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA CNPJ 01449930000190 AV MUTINGA 3800 PIRITUBA SÃO PAULO SP FABRICANTE SIEMENS AG SIEMENS MEDICAL SOLUTIONS USA INC ONCOLOGY ROENTGENSTRASSE 1921 D95478 KEMNATH 4040 NELSON AVENUE CONCORD CALIFORNIA 94520 ALEMANHA ESTADOS UNIDOS |
| Models | 70-4118, 10234230073, 70-4203, 10234230125 |
| Date | Mar 16, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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