International safety notice
Bone disintometry device
Brazil / Anvisa · BRA · Dec 15, 2015
Key facts
| Title | Bone disintometry device |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Prodigy Lunar Bone Densitometer ANVISA registration number: 80071260163 Risk class: III Model(s) affected; The following software versions: 15, 15 SP1 and 15 SP2 are affected of the products: - DPX Lunar Bone Densitometer (Model: DPX - NT and Registration: 80071260176). - Bone Densitometry System (Model: Lunar iDXA and Registration: 80071260178) - Prodigy Lunar Bone Densitometer (Model: Prodigy, Prodigy Advance, Prodigy Primo and Prodigy Pro - Registration: 80071260163). |
| Manufacturer | NOME DA EMPRESA FABRICANTE GE MEDICAL SYSTEMS ULTRASOUND PRIMARY CARE DIAGNOSTICS LLC PAÍS ESTADOS UNIDOS ENDEREÇO 3030 OHMEDA DRIVE MADISON WI 537186704 DETENTOR DE REGISTRO NO BRASILGE HEALTHCARE DO BRASIL ENDEREÇO AV MAGALHÃES DE CASTRO Nº4800 13ANDAR CIDADE JARDIM |
| Models | 80071260176, 80071260178, 80071260163 |
| Date | Dec 15, 2015 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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