International safety notice
Alert 2744 (Technosurveillance) - Shimadzu do Brasil Comércio Ltda - Bransist Alexa - Possibility of difficulty viewing the image due to synchronization error;
Brazil / Anvisa · BRA · Dec 19, 2018
Key facts
| Title | Alert 2744 (Technosurveillance) - Shimadzu do Brasil Comércio Ltda - Bransist Alexa - Possibility of difficulty viewing the image due to synchronization error; |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Business Name: Bransist Alexa Technical Name: Hemodynamics and Angiography Equipment ANVISA registration number: 10369010063 Risk Class: III Affected model: C12; Affected serial numbers: 4194ED23B001, 4194F0E41001, 4194EDC44001, 4194F0E45001, 4194EDC48001, 4194F0E61001, 41E581D7C001 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SHIMADZU DO BRASIL COMÉRCIO LTDA CNPJ 58752460000156 AVENIDA TAMBORÉ Nº 576 BAIRRO TAMBORE CEP 06460000 BARUERISP BARUERI SP TEL 11 24241785 EMAIL MBLASYSHIMADZUCOMBR FABRICANTE DO PRODUTO SHIMADZU CORPORATION 1 NISHINOKYOKUWABARACHO NAKAGYOKU KYOTO 604 8511 JAPÃO |
| Models | 4194F0E61001, 4194EDC44001, 41E581D7C001, 10369010063, 4194ED23B001, 4194EDC48001, 4194F0E45001, 4194F0E41001 |
| Date | Dec 19, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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