International safety notice
Alert 2571 (Technosurveillance) - GE Healthcare do Brasil - Optima Magnetic Resonance Imaging System Possibility of locking the transfer plate from the magnetic resonance table to the surgical table.
Brazil / Anvisa · BRA · May 23, 2018
Key facts
| Title | Alert 2571 (Technosurveillance) - GE Healthcare do Brasil - Optima Magnetic Resonance Imaging System Possibility of locking the transfer plate from the magnetic resonance table to the surgical table. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Optima Magnetic Resonance Imaging System Technical Name: Magnetic Resonance Equipment ANVISA registration number: 80071260300 Risk Class: II Affected model: OPTIMA MR450w GEM Affected serial numbers: 00000014131M67; |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO GE HEALTHCARE DO BRASIL COM E SERV PARA EQUIPAMENTOS MÉDICOHOSPITALARES LTDA CNPJ 00029372000140 AV MAGALHÃES DE CASTRO Nº 4800 11º ANDAR CIDADE JARDIM SÃO PAULO SP TEL 11 30678436 EMAIL TECNOVIGILANCIABRASILGECOM FABRICANTE DO PRODUTO GE MEDICAL SYSTEMS LLC 3200 NORTH GRANDVIEW BOULEVARD WUAKESHA WISCONSIN 53188 ESTADOS UNIDOS |
| Models | 00000021158M61, M0074SS, 00000014131M67, MR450w, 80071260300, 00000018480M64 |
| Date | May 23, 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