International safety notice
Alert 2865 (Technosurveillance) - GE Healthcare do Brasil, Com. E Serv.
Brazil / Anvisa · BRA · May 2, 2019
Key facts
| Title | Alert 2865 (Technosurveillance) - GE Healthcare do Brasil, Com. E Serv. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Ossea Achilles Ultrasound Equipment Technical Name: Ultrasound Device for Bone Densitometry ANVISA registration number: 80071260302 Risk Class: II Affected model: Achilles EXPII Affected serial numbers: ACH+62432 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO GE HEALTHCARE DO BRASIL COM E SERV PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA CNPJ 0029372000140 AV MAGALHÃES DE CASTRO N 4800 11º ANDAR CIDADE JARDIM SÃO PAULO SP TEL 3004 2525 CAPITAIS E REGIÕES METROPOLITANAS 0800 165 799 DEMAIS REGIÕES EMAIL TECNOVIGILANCIAGECOM FABRICANTE DO PRODUTO GE MEDICAL SYSTEMS CHINA CO LTD WUXI NATIONAL HITACH DEV ZONE NO19 CHANGJANG ROAD WUXI JIANGSU PROVINCE CHINA |
| Models | 62432, 80071260302 |
| Date | May 2, 2019 |
| 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