International safety notice
Alert 2611 (Technovigilance) - Fresenius Medical Care Ltda - Hemodialysis Machine 5008 - Need to change the lower body weight limit for using the machine.
Brazil / Anvisa · BRA · Jul 11, 2018
Key facts
| Title | Alert 2611 (Technovigilance) - Fresenius Medical Care Ltda - Hemodialysis Machine 5008 - Need to change the lower body weight limit for using the machine. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Hemodialysis Machine 5008 Technical Name: Hemodialysis Device ANVISA registration number: 80133950109 Risk Class: III Affected model: Online Plus Affected serial numbers: 7VEAGU39; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO FRESENIUS MEDICAL CARE LTDA CNPJ 01440590000136 RUA AMOREIRA 891 BAIRRO JARDIM ROSEIRA JAGUARIÚNA SP TEL 21 21792452 EMAIL VERAPEREIRAFMCAGCOM FABRICANTE DO PRODUTO FRESENIUS MEDICAL CARE AG CO KGAA 61346 BAD HOMBURG ALEMANHA |
| Models | 7VEAGU42, 7VEAHY09, 7VEAHW22, 7VEAGU43, 7VEAHY08, 7VEAGU39, 7VEAHY07, 7VEAHY10, 80133950109, 7VEAGU41, 7VEAGU40, 7VEAHY11 and 1 more |
| Date | Jul 11, 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