International safety notice
Alert 2745 (Technosurveillance) - Terumo - Electromedical System for Therapy - THERAKOS® CELLEX® Photopheresis System - Possibility of thromboembolic events in the treatment of Graft-versus-Host Disease (GVHD).
Brazil / Anvisa · BRA · Dec 19, 2018
Key facts
| Title | Alert 2745 (Technosurveillance) - Terumo - Electromedical System for Therapy - THERAKOS® CELLEX® Photopheresis System - Possibility of thromboembolic events in the treatment of Graft-versus-Host Disease (GVHD). |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Electromedical System for Therapy - THERAKOS® CELLEX® Photopheresis System Technical Name: Photopheresis Equipment ANVISA registration number: 80554210043 Risk Class: III Affected model: THERAKOS® CELLEX® Affected serial numbers: 40863; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO TERUMO BCT TECNOLOGIA MÉDICA LTDA CNPJ 10141389000149 RUA DO RÓCIO 220 CONJUNTO 41 SÃO PAULO SP TEL 11 28992612 28992620 EMAIL MAYRABAPTISTATERUMOBCTCOM LENITAGNOCHITERUMOBCTCOM FABRICANTE DO PRODUTO THERAKOS INC 10 NORTH HIGH STREET SUITE 300 WEST CHESTER PA 19380 |
| Models | 40863, 40926, 40919, 40923, 40925, 40922, 40920, 40921, 40918, 80554210043, 40924 |
| Date | Dec 19, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No 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