International safety notice
Alert 2642 (Technovigilance) - Dräger Indústria e Comércio Ltda - JM-105 Jaundice Meter - Symbol used to indicate a measurement outside the measurement range (-O-) of the device can lead the user to interpret the measurement as zero.
Brazil / Anvisa · BRA · Aug 10, 2018
Key facts
| Title | Alert 2642 (Technovigilance) - Dräger Indústria e Comércio Ltda - JM-105 Jaundice Meter - Symbol used to indicate a measurement outside the measurement range (-O-) of the device can lead the user to interpret the measurement as zero. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: JM-105 Jaundice Meter Technical Name: Skin Color Meter ANVISA registration number: 10407379016 Risk Class: II Affected model: JM-105 Jaundice Meter Affected serial numbers: See List of serial numbers at risk |
| 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 KONICA MINOLTA OPTICS INC JAPÃO LOCAL DE FABRICAÇÃO DRÄGER MEDICAL SYSTEMS INC LEGAL 3135 QUARRY ROAD TELFORD PA 189691042 EUA |
| Models | JM-105, 10407379016 |
| Date | Aug 10, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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