Dispositivos

Nombre Clasificación Fabricante Nivel de riesgo País Fuente
RaySearch RayStation 5 (Radiation therapy treatment planning system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RaySearch RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) (Radiation therapy treatment planning system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
1.5 mm HYDRO LeMaitre Valvulotome, 40 cm(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
IntelePACS InteleViewer software 4-10-1 and earlier versions (Picture archiving and communication system for radiology) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RayStation 3.0, 3.5, 4.0, 4.5, 4.7, and 5(Radiation therapy treatment planning system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge iConnect Enterprise Archive (iCEA) with software versions: 5.30.0 and greater up to and including 9.4.3(a picture archiving and communications system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2, 7.0 and greater up to and including 7.0.2 (picture archiving and communication system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge PACS with software versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1 (picture archiving and communication system)Distributed from May 2014 Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge PACS with software versions 6.0MR2 and greater up to and including 6.6.2.2. Merge PACS versions 7.0 and greater up to and including 7.0.2 (a picture archiving and communication system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge OrthoCase with software versions 3.7.3 and earlier (a picture archiving and communications system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge CADstream with software versions earlier than 5.2.6. Distributed prior to March 2008 CADstream version 5.2.6 and newer are not affected by this recall. Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge CADstream, All versions (used for breast cancer or general MRI studies) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge iConnect Enterprise Archive (iCEA) with software versions 8.30.7 through 9.4.3, with tier 2 storage enabled (a picture archiving and communications system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge PACS with software versions 6.5.5, 6.5.6, 6.5.7, 6.5.8, 6.5.9, 6.6, 6.6.1, 6.6.1.1, 6.6.2 (picture archiving and communication system) Distributed between June 2008 and June 2015 Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge PACS with software versions V6.0.2.0 MR2 and earlier (a picture archiving and communications system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge PACS (Amicas PACS) with software versions 6.0.2.0 MR2, 6.0.3.0 MR3, 6.0.3.1 MR3 CU1 (used for medical imaging acquisition) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Merge iConnect Enterprise Archive (iCEA) with software versions 8.80 through 9.4.4 (a picture archiving and communications system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RaySearch RayStation 5 (Radiation therapy treatment planning system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
G-scan Brio Magnetic Resonance System Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Vaxcel and Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC Triple Lumen with Endexo and PASV Valve Technology/Kits Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
INTELEPACS Versions 4.5.1 to 4.12.1(Radiology picture archiving and communication system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
Dexcom G4 PLATINUM and Dexcom G5 Mobile receiver (Continuous Glucose Monitoring Device). Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
IntelePACS InteleViewer software version 4.11.1 P144 (Radiology picture archiving and communication system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
RayStation 3.0, 3.5, 4.0, 4.5 and 4.7 (Radiation therapy treatment planning system) Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia
LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm Emergo Asia Pacific Pty Ltd T/a Emergo Australia Australia