International safety notice
Alert 2583 (Technosurveillance) - Baxter Hospitalar - Prismaflex Monitor - Failure of electronic components may compromise the correct functioning of the device.
Brazil / Anvisa · BRA · Jun 4, 2018
Key facts
| Title | Alert 2583 (Technosurveillance) - Baxter Hospitalar - Prismaflex Monitor - Failure of electronic components may compromise the correct functioning of the device. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Prismaflex Monitor Technical Name: Prismaflex control unit ANVISA registration number: 80145240438 Risk Class: III Affected model: 955052, 114489, 107493 and 113082 Affected serial numbers: See Attached List, annex 1 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BAXTER HOSPITALAR CNPJ 49351786000180 AVENIDA DR CHUCRI ZAIDAN Nº 1240 TORRE B 12º ANDAR VILA SÃO FRANCISCO SÃO PAULO SP TEL 11 56948877 EMAIL CINTIAGUEDESBAXTERCOM FABRICANTE DO PRODUTO GAMBRO INDUSTRIES 7 AVENUE LIONEL TERRAY 69883 MEYZIEU CEDEX FRANÇA |
| Models | 114489, 955052, 80145240438, 107493, 113082 |
| Date | Jun 4, 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