International safety notice
Alert 2725 (Technovigilance) - Siemens Healthcare Diagnósticos Ltda - SPECT Symbia - Incorrect external ECG electrical connection label on the patient table and in the Instruction Manual.
Brazil / Anvisa · BRA · Nov 8, 2018
Key facts
| Title | Alert 2725 (Technovigilance) - Siemens Healthcare Diagnósticos Ltda - SPECT Symbia - Incorrect external ECG electrical connection label on the patient table and in the Instruction Manual. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: SPECT Symbia Technical Name: Nuclear Image Formation System ANVISA registration number: 10345162043 Risk Class: III Affected model: Symbia Evo Affected serial numbers: 1315; |
| 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 | 10345162043 |
| Date | Nov 8, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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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