International safety notice
Alert 2555 (Technosurveillance) GE Healthcare - Bone Densitometry / Osseo Lunar Dpx Densitometer / Osseo Lunar Dpx Densitometer / Lunar Bone Densitometer Prodigy Information about the patient may be exchanged under certain conditions.
Brazil / Anvisa · BRA · Apr 26, 2018
Key facts
| Title | Alert 2555 (Technosurveillance) GE Healthcare - Bone Densitometry / Osseo Lunar Dpx Densitometer / Osseo Lunar Dpx Densitometer / Lunar Bone Densitometer Prodigy Information about the patient may be exchanged under certain conditions. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Bone Densitometry / Osseo Lunar Dpx Densitometer / Osseo Lunar Dpx Densitometer / Lunar Bone Densitometer Prodigy Technical name: Bone Desyntometry Device ANVISA registration number: 80071260174; Risk class: III Affected model: DPX Bravo, DPX-Duo (80071260174) / DPX-NT (80071260176) / DPX-MD+ (80035360019) / Prodigy, Prodigy Advance (80071260163) Affected Lot/Series Numbers: PA+130268; |
| 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 PATRICIASANTANAGECOM FABRICANTE GE MEDICAL SYSTEMS ULTRASOUND PRIMARY CARE DIAGNOSTICS LLC 3030 OHMEDA DRIVE MADISON WI ESTADOS UNIDOS |
| Models | LNR73479, LNR41569, 80071260163, 130268, 80035360019, 80071260176, 80071260174, LNR74315, LNR150180 |
| Date | Apr 26, 2018 |
| 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