International safety notice
Alert 2500 (Technosurveillance) - Philips - HeartStart FRx Device may not deliver shock when needed Device may not deliver shock when needed
Brazil / Anvisa · BRA · Feb 27, 2018
Key facts
| Title | Alert 2500 (Technosurveillance) - Philips - HeartStart FRx Device may not deliver shock when needed Device may not deliver shock when needed |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: HeartStart FRx Technical name: Defibrillator ANVISA registration number: 10216710172 Risk class: III Affected model: Affected serial number: See attached list |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO PHILIPS MEDICAL SYSTEMS LTDA CNPJ 58295213000178 AV TAMBORÉ 14001440 BOX 31 A 33 TAMBORÉ BARUERI SÃO PAULO FABRICANTE PHILIPS MEDICAL SYSTEMS 22100 BOTHELL EVERETT HIGHWAY BOTHELL WA 98021 EUA EMAIL REGULATORIOSPHILIPSCOM |
| Models | 10216710172 |
| Date | Feb 27, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 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