International safety notice
Alert 2528 (Technosurveillance) - H. Strattner - Focos Surgicos Aurinio Trilux Cracks in the support structure may result in breakage of the structure.
Brazil / Anvisa · BRA · Mar 28, 2018
Key facts
| Title | Alert 2528 (Technosurveillance) - H. Strattner - Focos Surgicos Aurinio Trilux Cracks in the support structure may result in breakage of the structure. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Aurinio Surgical Lights - Trilux Technical name: Surgical Focus ANVISA registration number: 10302860156 Risk class: I Affected model: LED SURGICAL FOCUS Aurinio L110, L120, L150 and L160. Affected serial numbers: 250; 212; 220; 221; 257; 256; 258; 263. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO H STRATTNER E CIA LTDA CNPJ 33250713000162 RUA RICARDO MACHADO 904 VASCO DA GAMA RIO DE JANEIRO RJ FABRICANTE TRILUX MEDICAL GMBH CO KG HEIDESTRASSE D59759 ARNSBERG ALEMANHA SPOONTRILUXMEDICALCOM |
| Models | 10302860156 |
| Date | Mar 28, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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