International safety notice
Technical name: Apheresis System
Brazil / Anvisa · BRA · Jun 23, 2017
Key facts
| Title | Technical name: Apheresis System |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: Spectra Optia Apheresis System Technical name: Apheresis System ANVISA registration number: 80554210002 Risk class: III Affected serial numbers: 1P04097 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO TERUMO BCT TECNOLOGIA MÉDICA LTDA CNPJ 10141389000149 ENDEREÇO RUA DO RÓCIO 220 CONJUNTO 41 VILA OLÍMPIA SÃO PAULOSP TELEFONE 11 28992612 E 11 28992620 FABRICANTE TERUMO BCT INC ENDEREÇO 10811 W COLLINS AVENUE LAKEWOOD COLORADO ZIP CODE 80215 ESTADOS UNIDOS DA AMÉRICA |
| Models | 1P04097, 80554210002 |
| Date | Jun 23, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 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