International safety notice
Alert 2812 (Technological Surveillance) - Philips - SureSigns VS Vital Signs Monitor and SureSigns Vital Signs Monitor - Possibility of overheating or fire in monitors with lithium-ion batteries that have exceeded their useful life.
Brazil / Anvisa · BRA · Mar 12, 2019
Key facts
| Title | Alert 2812 (Technological Surveillance) - Philips - SureSigns VS Vital Signs Monitor and SureSigns Vital Signs Monitor - Possibility of overheating or fire in monitors with lithium-ion batteries that have exceeded their useful life. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: SureSigns VS Vital Signs Monitor (registration 10216710328); Technical Name: Vital Signs Monitor ANVISA registration number: 10216710328; Risk Class: III Affected model: Registration 10216710328:SureSigns Vsi, SureSigns VS2+, SureSigns VS4. Affected serial numbers: See attachment "List of serial numbers at risk" |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO PHILIPS MEDICAL SYSTEMS LTDA CNPJ 58295213000178 AV TAMBORÉ 14001440 BOX 31 A 33 TAMBORÉ BARUERI SÃO PAULO TEL 11 995576799 EMAIL TECNOVIGILANCIABRPHILIPSCOM FABRICANTE DO PRODUTO PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN ROAD ANDOVER MA 01810 EUA |
| Models | 10216710171, 10216710328 |
| Date | Mar 12, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 100–999 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