International safety notice
Alert 2599 (Technosurveillance) - Bard do Brasil - Arctic Sun - Temperature Control Equipment - Possibility of overheating due to an inadequate cabling connection in the chiller assembly.
Brazil / Anvisa · BRA · Jun 28, 2018
Key facts
| Title | Alert 2599 (Technosurveillance) - Bard do Brasil - Arctic Sun - Temperature Control Equipment - Possibility of overheating due to an inadequate cabling connection in the chiller assembly. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Arctic Sun - Temperature Control Equipment Technical Name: Body Temperature Control Equipment ANVISA registration number: 80689090025 Risk Class: III Affected model: 50000006 - 110 V and 50000105 - 220 V Affected serial numbers: Code: 50000105 Serial numbers: 5083; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BARD DO BRASIL INDUSTRIA E COMERCIO DE PRODUTOS PARA SAÚDE LTDA CNPJ 10818693000188 RUA ALEXANDRE DUMAS 2100 10º ANDAR CHÁCARA SANTO ANTONIO SÃO PAULO SP TEL 1151800222 EMAIL SANDRABRAMUCCICRBARDCOM FABRICANTE DO PRODUTO MEDIVANCE INC 321 SOUTH TAYLOR AVENUE SUITE 200 LOUSVILLE COLORADO ESTADOS UNIDOS |
| Models | 80689090025, 50000105, 50000006 |
| Date | Jun 28, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 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