International safety notice
Alert 2615 (Technosurveillance) - Siemens Healthcare - SOMATOM Definition AS, SOMATOM Definition Edge - Possibility of unnecessary exposure to radiation during tomography based on p.a (posterior-anterior) or a.p. topograms.
Brazil / Anvisa · BRA · Jul 13, 2018
Key facts
| Title | Alert 2615 (Technosurveillance) - Siemens Healthcare - SOMATOM Definition AS, SOMATOM Definition Edge - Possibility of unnecessary exposure to radiation during tomography based on p.a (posterior-anterior) or a.p. topograms. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Nome Comercial: Somatom Definition AS, Somatom Definition Edge, Somatom Definition Flash Technical Name: Computed Tomography Equipment ANVISA registration number: 10345161981; Risk Class: III Affected model: see attached product data Affected serial numbers: 66050, 66806, 95261, 95426, 95637, 95981, 96599, 96809, 96862, 96988, 96989, 83605, 83650, 83656 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA CNPJ 01449930000190 AV MUTINGA 3800 4º E 5º ANDAR PIRITUBA SÃO PAULO SP TEL 11 39082132 EMAIL FELIPEDEMELOFARIASIEMENSHEALTHINEERSCOM FABRICANTE DO PRODUTO SIEMENS HEALTHCARE GMBH HENKESTRASSE 127 91052ERLANGEN ALEMANHA |
| Models | 95637, 95981, 10345161981, 96989, 96599, 95426, 96862, 83656, 66050, 83605, 10345161989, 66806 and 5 more |
| Date | Jul 13, 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