International safety notice
Alert 2541 (Technosurveillance) - Philips - Azurion Measurements carried out with the system may not be exported correctly, resulting in potentially erroneous results.
Brazil / Anvisa · BRA · Apr 16, 2018
Key facts
| Title | Alert 2541 (Technosurveillance) - Philips - Azurion Measurements carried out with the system may not be exported correctly, resulting in potentially erroneous results. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Azurion Technical name: Hemodynamics and Angiography Equipment ANVISA registration number: 10216710345 Risk class: III Affected model: 3 and 7 Affected serial numbers: 151; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO PHILIPS MEDICAL SYSTEMS LTDA CNPJ 58295213000178 AV TAMBORÉ 14001440 BOX 31 A 33 TAMBORÉ BARUERI SÃO PAULO TEL 11 21250023 EMAIL LARISSAFRIASPHILIPSCOM FABRICANTE PHILIPS MEDICAL SYSTEMS NEDERLAND B V VEENPLUIS 46 5584 PC BEST HOLANDA EMAIL REGULATORIOSPHILIPSCOM |
| Models | 10216710345 |
| Date | Apr 16, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 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