International safety notice
Alert 2891 (Technosurveillance) - GE Healthcare - Discovery PET/CT - Optima PET/CT 560 System.
Brazil / Anvisa · BRA · May 29, 2019
Key facts
| Title | Alert 2891 (Technosurveillance) - GE Healthcare - Discovery PET/CT - Optima PET/CT 560 System. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Discovery PET/CT (registration 80071260295); Technical Name: Positron Emission Tomography and Computed Tomography (PET/CT) Equipment ANVISA registration number: 80071260295; Risk Class: III Affected model: registration 80071260295: Discovery PET/CT 610, Discovery PET/CT 710, Discovery MI, Discovery MI Digital Ready; Affected serial numbers: PET14656PT3; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO GE HEALTHCARE DO BRASIL COM E SERV PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA CNPJ 00029372000140 AV MAGALHÃES DE CASTRO Nº 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 LLC 3000 NOTH GRANDVIEW BOULEVARD WAUKESHA WI 53188 ESTADOS UNIDOS |
| Models | PTC151700033PT, PET13394PT2, PET13359PT5, PET14686PT0, PET465924HM9, 80071260344, PET13340PT5, CJRPX1700082CN, 80071260295, PTDMI1700025PT, PET13330PT6, PET13456PT9 and 19 more |
| Date | May 29, 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