International safety notice
Alert 2586 (Technosurveillance) - Sirona Dental - Image Acquisition System for Cerec AC Restoration Alert message reinforcing that the device's pulsed light can cause epilepsy attacks in patients.
Brazil / Anvisa · BRA · Jun 12, 2018
Key facts
| Title | Alert 2586 (Technosurveillance) - Sirona Dental - Image Acquisition System for Cerec AC Restoration Alert message reinforcing that the device's pulsed light can cause epilepsy attacks in patients. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Cerec AC Restoration Image Acquisition System Technical Name: Instrument for Dentistry ANVISA registration number: 80745400003 Risk Class: I - Low Risk Affected model: 6371830 Cerec AC Omnicam / 6431519 Cerec AC Connect Omnicam Affected serial numbers: See attached document Distribution Map. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SIRONA DENTAL COMÉRCIO DE PRODUTOS E SISTEMAS ODONTOLÓGICOS LTDA CNPJ 12483930000122 R SEN CARLOS GOMES DE OLIVEIRA Nº 863 CD 02 UN 63 DISTR INDUSTRIAL CEP 88104785 SÃO JOSÉ SC TEL 11 30462433 EMAIL JOAOZANUZZODENTSPLYSIRONACOM FABRICANTE DO PRODUTO SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 64625 BENSHEIM ALEMANHA |
| Models | 6431519, 6371830, 80745400003 |
| Date | Jun 12, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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