International safety notice
Alert 2531 (Technosurveillance) Fujifilm - Digital Mammography System - Amulet Innovality Risk of C-Arm unlocking, resulting in injuries to operators or patients.
Brazil / Anvisa · BRA · Mar 29, 2018
Key facts
| Title | Alert 2531 (Technosurveillance) Fujifilm - Digital Mammography System - Amulet Innovality Risk of C-Arm unlocking, resulting in injuries to operators or patients. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Digital Mammography System - Amulet Innovality Technical name: Mammography Device ANVISA registration number: 80022060030 Risk class: III Affected model: (FDR-3500 DRLH) Affected serial numbers: 57220649, 66120659, 66120660, 66220706, 66220707, 66220708, 66220709, 66420762, 66420763, 66720855, 66720856, 66720 859, 66720860, 66720860, 66720861, 66720861, 67221038, 67221039, 67221040, 76421200, 76421202, 76421204 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO FUJIFILM DO BRASIL LTDA CNPJ 60397874000156 AVENIDA IBIRAPUERA 2315 15 E 16 ANDAR INDIANÓPOLIS SÃO PAULO SP FABRICANTE FUJIFILM TECHNO PRODUCTS CO LTD 213 KITAYUGUCHI HANAMAKISHI IWATE 0250301 JAPÃO KOJIKUWAHARAFUJIFILMCOM |
| Models | 66720861, 57220649, FDR-3500, 67221040, 66720860, 76421202, 66220708, 66720859, 66220707, 76421200, 66120660, 66120659 and 10 more |
| Date | Mar 29, 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