International safety notice
Alert 2508 (Technovigilance) - WEM Equipamentos Eletronicos Ltda - Double Pedal FS-14 component of models HF-120 / SS 200-E Pedal function is inverted the scalpel makes the cut when in coagulation mode and vice versa
Brazil / Anvisa · BRA · Mar 12, 2018
Key facts
| Title | Alert 2508 (Technovigilance) - WEM Equipamentos Eletronicos Ltda - Double Pedal FS-14 component of models HF-120 / SS 200-E Pedal function is inverted the scalpel makes the cut when in coagulation mode and vice versa |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name: Double Pedal FS-14 component of the HF-120 / SS 200-E models Technical name: Microprocessed Electronic Scalpel ANVISA registration number: 10247670035 Risk class: III Affected model: HF-120 / SS 200-E Affected serial number: 8020140101; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO WEM EQUIPAMENTOS ELETRONICOS LTDA CNPJ 54611678000130 RUA MARECHAL MASCARENHAS DE MORAES 550 SÃO PAULO SP FABRICANTE WEM EQUIPAMENTOS ELETRONICOS LTDA RUA MARECHAL MASCARENHAS DE MORAES 550 BRASIL TELEFONE 16 3512 4623 FAX 16 3512 4600 EMAIL NESSERCDEPAULAMEDTRONICCOM |
| Models | 8020950101, HF-120, 8003380101, 8025670101, 10247670035, FS-14, 200-E, 8017000101, 8003040101, 8020140101 |
| Date | Mar 12, 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