Dispositivos

Nombre Clasificación Fabricante Nivel de riesgo País Fuente
4FR Single Lumen Pressure Injectable Peripherally Inserted Central Catheter (PICC) General Hospital and Personal Use Devices Teleflex Medical Australia Pty Ltd Australia
Flexi-Slip endotracheal tube stylets(Intended for use in facilitating intubation of tracheal tubes.) Teleflex Medical Australia Pty Ltd Australia
Arrow International 4Fg Seldinger Conversion Set with Long Sheath(Peripherally inserted central venous catheter) Teleflex Medical Australia Pty Ltd Australia
AQUAPAK BRITISH and INTL 340 SW, 340 ML W/040B Humidifier Adaptors Teleflex Medical Australia Pty Ltd Australia
Hudson Nebuliser Adaptor - AQUAPAK Teleflex Medical Australia Pty Ltd Australia
Surveyor S12 and Surveyor S19 Patient MonitorsMultiple part numbers and serial numbers affected Mortara Instrument Australia Pty Ltd Australia
Rocket IPC Drainage Bottle (A collection device used to collect fluid or air from the pleural cavity) Rocket Medical Pty Ltd Australia
Relief ACP Oral Care Gel supplied separately and in Zm CH 25% KitsRelief ACP 6-Syr w/Tray Case Dom Discus Dental Australia Pty Ltd Australia
ArthroCare Corporation HipVac 50 Coblation Wand Arthrocare Australasia Pty Ltd Australia
Rigid Arm Supports(used as part of Posiboard-2 and Positrest) Radiology Devices alphaXRT Pty Ltd Australia
AlignRT patient positioning/tracking video camera system (when used withTrueBeam Radiotherapy Delivery System) Radiology Devices alphaXRT Pty Ltd Australia
AlignRT patient positioning/tracking video camera system Software versions up to, but not including, 5.0.1691 Affected hardware configuration: Vision RT external Gate Controller with Varian Motion Management Interface (MMI) or Siemens systems. Systems with Vision RT’s Integrated Gate Controller (IGC) are not affected. alphaXRT Pty Ltd Australia
FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits Scott Health and Safety Australia
AtriCure CryoICE cryo-ablation probe (CRYO2) General and Plastic Surgery Devices N Stenning & Co Pty Ltd Australia
EZ1 Advanced XL instrument. An in vitro diagnostic medical device (IVD) Qiagen Pty Ltd Australia
EZ1 DSP Virus Kit (48). An in vitro diagnostic medical device (IVD). Qiagen Pty Ltd Australia
therascreen PyroMark Gold Q24 Reagents and Pyro Buffers. An in vitro diagnostic medical device (IVD) Qiagen Pty Ltd Australia
QIAsymphony DSP DNA Mini Kits. An in vitro diagnostic medical device (IVD). Qiagen Pty Ltd Australia
artus C. trachomatis Plus kits (used for the detection of plasmid free variants of Chlamydia trachomatis) Qiagen Pty Ltd Australia
QIAsymphony DSP Virus/Pathogen Midi Kit. An in vitro Diagnostic Medical Device (IVD)(DNA/RNA purification system) Qiagen Pty Ltd Australia
PharmAust 30ml Chlorhexidine in Ethanol 70% (Red Tint) JMAC (WA) Pty Ltd trading as PharmAust Manufacturing Australia
SONY LMD-1951MD MONITORS General and Plastic Surgery Devices Sony Australia Limited Australia
SIM System with SIM dock power supply model Franmar FRA012-S05-I Simavita Aust Pty Ltd Australia
Airlight ROM brace (An Orthosis that encompases the knee joint) Australian Orthotic Technologies Pty Ltd Australia
Acutronic Fabian HFO (High Frequency Oscillation) Ventilators , software versions below GUI 3.0.2.7PN 7200 Medical Technologies Pty Ltd Australia