International safety notice
Alert 2558 (Technosurveillance) - Siemens - Somatom computed tomography equipment Possibility of unnecessary exposure to radiation during tomography based on p.a (posterior-anterior) or a.p. topograms.
Brazil / Anvisa · BRA · Apr 26, 2018
Key facts
| Title | Alert 2558 (Technosurveillance) - Siemens - Somatom computed tomography equipment Possibility of unnecessary exposure to radiation during tomography based on p.a (posterior-anterior) or a.p. topograms. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Somatom Emotion computed tomography equipment Technical name: Computed Tomography Equipment ANVISA registration number: 10345161972 Risk class: III Modelo afetado: SOMATOM Emotion 16 (2007); SOMATOM Emotion 16 Slice (BR); SOMATOM Emotion 6 (2007); SOMATOM Emotion 6 Slice (BR) Affected serial numbers: See attachment List of Series at Risk Trade name: Somatom Spirit Computed Tomography Equipment Siemens Brand Technical name: Computed Tomography Equipment ANVISA registration number: 10345162002 Risk class: III Modelo afetado: SOMATOM Spirit (BR); SOMATOM Spirit; SOMATOM Spirit Power; SOMATOM Spirit Power (BR) Affected serial numbers: See attachment List of Series at Risk Trade name: Somatom Scope Power Computed Tomography Equipment Technical name: Computed Tomography Equipment ANVISA registration number: 10345161975 Risk class: III Modelo afetado: SOMATOM Scope (BR); SOMATOM Scope Power (BR); SOMATOM Scope Affected serial numbers: See attachment List of Series at Risk Trade name: Somatom Perspective Computed Tomography Equipment Technical name: Computed Tomography Equipment ANVISA registration number: 10345162001 Risk class: III Affected model: SOMATOM Perspective 64/128 (BR); Affected serial numbers: See attachment List of Series at Risk |
| 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 SIEMENS HEALTHCARE GMBH HENKESTRASSE 127 91052ERLANGEN ALEMANHA |
| Models | 10345162002, 10345162001, 10345161972, 10345161975 |
| Date | Apr 26, 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