International safety notice
Alert 2643 (Technovigilance) - Dräger Indústria e Comércio Ltda - JM-103 Jaundice Meter - Symbol used to indicate measurement outside the measurement range (---) of the device may impair the interpretation of the result.
Brazil / Anvisa · BRA · Aug 13, 2018
Key facts
| Title | Alert 2643 (Technovigilance) - Dräger Indústria e Comércio Ltda - JM-103 Jaundice Meter - Symbol used to indicate measurement outside the measurement range (---) of the device may impair the interpretation of the result. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: JM 103 Jaundice Meter Technical Name: Skin Color Meter ANVISA registration number: 10407379016 Risk Class: II Affected model: JM-103 Affected serial numbers: 3204310; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO DRÄGER INDÚSTRIA E COMÉRCIO LTDA CNPJ 02535707000128 ALAMEDA PUCURUÍ 51 TAMBORÉ BARUERI SP TEL 11 46894415 EMAIL DENISESOUZADRAEGERCOM FABRICANTE DO PRODUTO DRÄGER MEDICAL SYSTEMS INC 3135 QUARRY ROAD TELFORD PA 189691042 EUA |
| Models | 3206003, 3206159, 3205963, 3206244, 3206030, 3205574, 3204534, 3205884, 3205882, 3206026, 3206217, 3205916 and 54 more |
| Date | Aug 13, 2018 |
| 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