International safety notice
Alert 2592 (Technovigilance) - Siemens Healthcare Diagnósticos Ltda - POSITRON EMISSION TOMOGRAPHY EQUIPMENT Possibility of increasing dosage in head acquisitions using PA or AP topogram with CARE Dose4D.
Brazil / Anvisa · BRA · Jun 25, 2018
Key facts
| Title | Alert 2592 (Technovigilance) - Siemens Healthcare Diagnósticos Ltda - POSITRON EMISSION TOMOGRAPHY EQUIPMENT Possibility of increasing dosage in head acquisitions using PA or AP topogram with CARE Dose4D. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Positron Emission Tomography Equipment Technical Name: Positron Emission Tomography Equipment ANVISA registration number: 10345162013; Risk Class: III Modelo afetado: BIOGRAPH 16; BIOGRAPH 6; BIOGRAPH 6 TruePoint; BIOGRAPH 16 TruePoint TV; BIOGRAPH 16 TruePoint; BIOGRAPH mCT-X 4RN; BIOGRAPH mCT-S40 4; BIOGRAPH mCT-S64 4R; BIOGRAPH mCT Flow; 20-3R; BIOGRAPH Horizon - 3R; BIOGRAPH 64-3R TruePoint; BIOGRAPH mCT 20 Excel. Affected serial numbers: 1322; |
| 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 MEDICAL SOLUTIONS USA INC MOLECULAR IMAGING 2501 N BARRINGTON ROAD HOFFMAN ESTATES ILLINOIS 601922061 ESTADOS UNIDOS |
| Models | 94445, 45631, 72501, 72453, 11045, 45663, 72475, 21077, 59003, 72511, 31081, mCT-S64 and 38 more |
| Date | Jun 25, 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