International safety notice
Alert 2634 (Technosurveillance) - Siemens Healthcare Diagnósticos Ltda - Atellica CH Analyzers Family / Atellica IM Analyzers Family - Software update with the aim of solving various device operating problems.
Brazil / Anvisa · BRA · Aug 3, 2018
Key facts
| Title | Alert 2634 (Technosurveillance) - Siemens Healthcare Diagnósticos Ltda - Atellica CH Analyzers Family / Atellica IM Analyzers Family - Software update with the aim of solving various device operating problems. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Atellica CH Analyzers Family / Atellica IM Analyzers Family. Technical Name: Instrument for analysis of general biochemistry, hormones, drugs or proteins / Instrument intended for immunoassays. ANVISA registration number: 10345162153; Risk Class: II Modelo afetado: Atellica IM 1300 Analyzer, Atellica IM 1600 Analyzer, Atellica CH 930 Analyzer, Atellica Sample Handler Prime, Atellica Sample Handler Connect, Atellica Sample Handler Additional. Affected serial numbers: DL00157; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA AV MUTINGA 3800 4º E 5º ANDAR PIRITUBA SÃO PAULO SP TEL 11 3908 2132 EMAIL FELIPEDEMELOFARIASIEMENSHEALTHINEERSCOM FABRICANTE DO PRODUTO SIEMENS HEALTHCARE DIAGNOSTICS INC 511 BENEDICT AVENUE TARRYTOWN NEW YORK 10591 ESTADOS UNIDOS |
| Models | 10345162153, 10345162195, DL00157, SP00223 |
| Date | Aug 3, 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