International safety notice
Alert 2630 (Technosurveillance) - Siemens Healthcare Diagnósticos Ltda - Biograph mCT Positron Emission Tomography Equipment Electrical parts of the gantry may be exposed.
Brazil / Anvisa · BRA · Aug 2, 2018
Key facts
| Title | Alert 2630 (Technosurveillance) - Siemens Healthcare Diagnósticos Ltda - Biograph mCT Positron Emission Tomography Equipment Electrical parts of the gantry may be exposed. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Biograph mCT Positron Emission Tomography Equipment Technical Name: Positron Emission Tomography Equipment ANVISA registration number: 10345162013 Risk Class: III Modelos afetados: Biograph mCT-X 4R, Biograph mCT-S40 4R, Biograph mCT-S64 4R Affected serial numbers: 11033; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA AV MUTINGA 3800 4º E 5º ANDAR PIRITUBA SÃO PAULO SP TEL 11 39082132 EMAIL FELIPEDEMELOFARIASIEMENSHEALTHINEERSCOM FABRICANTE DO PRODUTO SIEMENS MEDICAL SOLUTIONS USA INC 2501 N BARRINGTON ROAD HOFFMAN ESTATES ILLINOIS 601922061 ESTADOS UNIDOS DA AMÉRICA |
| Models | mCT-S64, 11046, mCT-S40, 11033, 11072, 10345162013, 11045, 11036 |
| Date | Aug 2, 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