International safety notice
Alert 2758 (Technosurveillance) - GE Healthcare do Brasil - GE Discovery Nuclear Medicine System - Ventri Nuclear Imaging System - Possibility that the systems are operating with outdated software.
Brazil / Anvisa · BRA · Dec 28, 2018
Key facts
| Title | Alert 2758 (Technosurveillance) - GE Healthcare do Brasil - GE Discovery Nuclear Medicine System - Ventri Nuclear Imaging System - Possibility that the systems are operating with outdated software. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: GE Discovery Nuclear Medicine System | Technical Name: Nuclear Image Formation System | ANVISA registration number: 80071260124; Risk Class: II and III Affected model: Discovery NM 530c (80071260124) | Affected serial numbers: 2741194; |
| 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 ISRAEL FUNCTIONAL IMAGING 4 HAYOZMA STREET PO BOX 170 TIRAT HACARMEL 30200 ISRAEL |
| Models | 1355178XE, 2741194, 1318313, 2748067, 2748059, NM11456, NM11518, NM19197, NM11411, NM19079, NM11447, 2822534 and 29 more |
| Date | Dec 28, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
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