International safety notice
Alert 2811 (Technosurveillance) - Nidek Eyecare do Brasil Comércio de Instrumentos Opticos Ltda - Specular Microscope - Electromagnetic noise higher than the limit established by standard.
Brazil / Anvisa · BRA · Mar 11, 2019
Key facts
| Title | Alert 2811 (Technosurveillance) - Nidek Eyecare do Brasil Comércio de Instrumentos Opticos Ltda - Specular Microscope - Electromagnetic noise higher than the limit established by standard. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Specular Microscope Technical Name: Ophthalmic Microscope ANVISA registration number: 80625080016 Risk Class: II Affected model: CEM-530 Affected serial numbers: See attachment "List of serial numbers at risk" |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO NIDEK EYECARE DO BRASIL COMERCIO DE INSTRUMENTOS OPTICOS LTDA CNPJ 9632380000151 RUA PADRE ROMA 482 SALA 401 CENTRO FLORIANÓPOLIS SC TEL 48 33046000 EMAIL ENIOSATAKENIDEKBRCOM FABRICANTE DO PRODUTO NIDEK CO LTD 3414 MAEHAMA HIROISHI GAMAGORI AICHI 4430038 JAPÃO |
| Models | CEM-530, 80625080016 |
| Date | Mar 11, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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