International safety notice
Alert 2757 (Technosurveillance) - Maquet Cardiopulmonary do Brasil Industria e Comercio Ltda - HCU 40 Hypothermia/Hyperthermia System - Malfunction of flow sensors.
Brazil / Anvisa · BRA · Dec 28, 2018
Key facts
| Title | Alert 2757 (Technosurveillance) - Maquet Cardiopulmonary do Brasil Industria e Comercio Ltda - HCU 40 Hypothermia/Hyperthermia System - Malfunction of flow sensors. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: HCU 40 Hypothermia/Hyperthermia System Technical Name: Equipment for controlling body temperature ANVISA registration number: 10390690089 Risk Class: III Affected model: HCU-40 Affected serial numbers: 90440289; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO MAQUET CARDIOPULMONARY DO BRASIL INDÚSTRIA E COMÉRCIO LTDA CNPJ 00944324000188 AV MARGINAL DO RIBEIRÃO DOS CRISTAIS 500 CAJAMAR SP TEL 1126087387 EMAIL GUILHERMEPACINIGETINGECOM FABRICANTE DO PRODUTO MAQUET CARDIOPULMONARY GMBH KEHLER STR 31 76437 RASTATT ALEMANHA |
| Models | 90440288, 90440289, HCU-40, 10390690089 |
| Date | Dec 28, 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