International safety notice
Alert 2733 2nd Update (Technosurveillance) Siemens Equip.
Brazil / Anvisa · BRA · Nov 14, 2018
Key facts
| Title | Alert 2733 2nd Update (Technosurveillance) Siemens Equip. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial Name: Biograph mCT Positron Emission Tomography Equipment. Technical Name: Positron Emission Tomography Equipment. ANVISA registration number: 10345162013. Product Type: Equipment. Risk Class: III. Modelo afetado: BIOGRAPH mCT - X; BIOGRAPH mCT - S; BIOGRAPH mCT – Flow. Updated list of affected serial numbers: 1010, 31081, 59001, 11045, 11046, 11072, 11036, 21073, 21077, 21131, 21138, 59003, 59004, 60024, 11008, 94445, 2 1128. Access the full content of Alert 2733 with the respective annexes on the ANVISA Portal (http://portal.anvisa.gov.br/alertas). |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SIEMENS HEALTHCARE DIAGNÓSTICOS LTDA CNPJ 01449930000190 AV MUTINGA 3800 4º E 5º ANDAR PIRITUBA SÃO PAULO SP TEL 11 39081649 EMAIL JAQUELINESANTOSSIEMENSHEALTHINEERSCOM FABRICANTE DO PRODUTO SIEMENS MEDICAL SOLUTIONS USA INC MOLECULAR IMAGING 2501 N BARRINGTON ROAD HOFFMAN ESTATES ILLINOIS 601922061 ESTADOS UNIDOS |
| Models | 59003, 11045, 11072, 59004, 94445, 21138, 31081, 11036, 59001, 11008, 11046, 21131 and 5 more |
| Date | Nov 14, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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