International safety notice
Alert 2722 (Technosurveillance) - Olympus Optical do Brasil Ltda - USG-400 Ultrasonic Generator - Units with software version not updated in the product registration.
Brazil / Anvisa · BRA · Nov 6, 2018
Key facts
| Title | Alert 2722 (Technosurveillance) - Olympus Optical do Brasil Ltda - USG-400 Ultrasonic Generator - Units with software version not updated in the product registration. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: USG-400 Ultrasonic Generator Technical Name: High-frequency surgical equipment ANVISA registration number: 80124630189 Risk Class: III Affected model: USG-400 Affected serial numbers: 9812044 / 9811807 / 9812133 / 9812156 / 9812164 / 9812157 / 9812166 / 9812165 / 9812163 / 9812167 / 9812151 / 9812148 / 9812149 / 9812142 / 9812160 / 9812299 / 9812298 / 9812295. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO OLYMPUS OPTICAL DO BRASIL LTDA CNPJ 04937243000101 RUA DO RÓCIO 430 2º ANDAR VILA OLIMPIA SÃO PAULO SP TEL 30466400 RAMAL 6465 EMAIL QUALIDADEBRASILOLYMPUSCOM FABRICANTE DO PRODUTO OLYMPUS MEDICAL SYSTEMS CORP 2951 ISHIKAWA CHO HACHIOJISHI TOQUIO JAPÃO |
| Models | 9812164, 9812157, 9812167, 9812166, 9812299, 9812163, 80124630189, 9812142, 9812151, 9812165, 9812148, 9812044 and 8 more |
| Date | Nov 6, 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