International safety notice
Alert 2715 (Technosurveillance) - Becton Dickinson - BD FocalPoint GS Imaging System - Equipment may not operate at temperatures below the ambient temperature indicated on the operating label.
Brazil / Anvisa · BRA · Nov 1, 2018
Key facts
| Title | Alert 2715 (Technosurveillance) - Becton Dickinson - BD FocalPoint GS Imaging System - Equipment may not operate at temperatures below the ambient temperature indicated on the operating label. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: BD FocalPoint GS Imaging System Technical Name: Instrument for sample preparation and processing - pre-analytical phase ANVISA registration number: 10033430562 Risk Class: I Affected model: BD FocalPoint GS Imaging System Serial numbers: FP554, 450, 392 and 357 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO BECTON DICKINSON INDÚSTRIAS CIRÚRGICAS LTDA CNPJ 21551379000106 AVENIDA PRESIDENTE JUSCELINO KUBITSCHEK 273 JUIZ DE FORA MG TEL 11 5185 9990 EMAIL BRCRBDCOM FABRICANTE DO PRODUTO BECTON DICKINSON AND COMPANY 7 LOVETON CIR SPARKS MD 21152 EUA |
| Models | 10033430562, FP554 |
| Date | Nov 1, 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