Dispositivos

Nombre Clasificación Fabricante Nivel de riesgo País Fuente
Micro Curved Attachment (MCA) and MCA Cutting Burrs (Intended for use in delicate bone in otologic (ear) procedures such as cochleostomy) Synthes Australia Pty Ltd Australia
Expert Tibial Nail PROtect Ø 8.0 – 13.0 mm, cannulated, length 255 – 465 mm, Gentamicin Sulphate, Titanium Alloy (TAN), dark blue, sterile, (Antibiotic coated tibial nail) Synthes Australia Pty Ltd Australia
Cancellous Bone Impactor 6.0mm, Flattened (Supplied as part of the bone internal fixation system implantation kit) Synthes Australia Pty Ltd Australia
Crutches - Forearm Ergo Grip Tall and Forearm Ergo Grip Adult (one arm, walking aid crutch) Making Life Easy Mobility And Independent Living Superstore Pty Ltd Australia
NeoMed Enteral Feeding Tubes with EO Connectors Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RayStation and RayPlan Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
microTargeting Depth Stop Adapter; microTargeting STar Drive System (Manual); microTargeting STar Drive System (Motorised); microTargeting Drive System; microTargeting STar Drive System (Manual) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RayStation 6 (RayPlan 2) and RayStation 7 (RayPlan 7) when used with photon Collapsed Cone dose calculation Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
G5 Mobile Receiver Manufactured between January 2016 and February 2017 Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
ADT1018 and ADT1018-50 Flow QC Tubing – haemodialysis blood tubing Set Gastroenterology-Urology Devices Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
IMRIS ORT100 and ORT300 Operating Room Tables Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
IMRIS ORT100 and ORT300 Operating Room Tables Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RayStation and RayPlan Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
TomoTherapy High Performance Patient Couch Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RayStation and RayPlan Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
IntelePACS with software versions 4-3-1 and upAffected software versions: PACS 4-3-1 R49, PACS 4-3-2 R11, PACS 4-3-4 R39, PACS 4-6-1 R107, PACS 4-8-1 R65, PACS 4-9-1 R33, PACS 4-10-1 R61, PACS 4-11-1 R58, PACS 4-12-1 R45, PACS 4-14-1 R24, PACS 4-15-1 R7 Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
IntelePACS InteleViewer with software version 3-5-1 to 4-15-1 Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
ACQUITY UPLC Sample Organisers. An in vitro diagnostic medical device (IVD) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
LipiFlow System Activator (used as part of the LipiFlow Thermal Pulsation System) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
HYDRO LeMaitre Valvulotome Devices (intended for the treatment of vascular disorders and particularly for excising or disrupting venous valves) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
AnastoClip AC Closure System Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RaySearch RayStation 4.5, 4.7, 5, and 6(Radiation therapy treatment planning system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge eFilm Workstation/eFilm Lite versions 2.1, 2.1.2, 3.0, 3.1, 3.3.5, 3.4, 4.0, 4.0.1, 4.0.2, 4.0.3 and 4.1(Picture archiving and communication system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
BioFlo PICC with ENDEXO and PASV Valve Technology with Nitinol Guidewire - Catheterisation kit, central venous Description:Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nitinol GW PG Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
ROTAIO Cervical Disc Prosthesis Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia