International safety notice
Alert 2765 Rectification (Technosurveillance) Eckert & Ziegler Brasil Comercial Ltda Captus Family Possibility of failure of the articulating arm which could cause the collimator to fall.
Brazil / Anvisa · BRA · Jan 11, 2019
Key facts
| Title | Alert 2765 Rectification (Technosurveillance) Eckert & Ziegler Brasil Comercial Ltda Captus Family Possibility of failure of the articulating arm which could cause the collimator to fall. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Família Captus Technical Name: Thyroid Pickup ANVISA registration number: 80012590168 Risk Class: II Affected model: Captus 3000 Affected serial numbers (reported in the alert dated 01/11/2019): 1) Captus 3000; New serial numbers (rectification of alert 2765 on 04/18/2019): 901529, 901537, 901558, 901631, 901634, 901619, 901658. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO ECKERT ZIEGLER BRASIL COMERCIAL LTDA CNPJ 02887124000166 RUA CAMPOS SALES 303 SALA 709 BAIRRO CENTRO BARUERI SP BARUERI SP TEL 11 35265715 EMAIL RAQUELETIENNEEZAGCOM FABRICANTE DO PRODUTO CAPINTEC INC 7 VREELAND ROAD FLORHAM PARK NEW JERSEY 07932 ESTADOS UNIDOS |
| Models | 901558, 901155, 901631, 901658, 901537, 5430-0077, 901634, 80012590168, 901118, 901619, 901529 |
| Date | Jan 11, 2019 |
| 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