Medical Device Recalls

Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pul

GE MEDICAL SYSTEMS, ISRAEL LTD.

SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

Volcano Corporation

Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

C.R. Bard Inc

da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSC

Intuitive Surgical, Inc.

The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEO

Olympus Corporation of the Americas

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RaySta

RAYSEARCH LABORATORIES AB

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

W L Gore & Associates, Inc.

DeRoyal VIT RD PACK 86ST, REF 89-7308.09

DeRoyal Industries Inc

QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No.

Maquet Medical Systems USA

TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed fo

Echopixel, Inc.

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.

Olympus Corporation of the Americas

Product Name: CORFLO* Safety PEG Kit with ENFit¿ Connector Model/Catalog Number: 50-4320

Avanos Medical, Inc.

Atrium Oasis Drain Single W / AC, Part No. 3600-100

Atrium Medical Corporation

EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator

Medtronic Inc.

Artis zee floor MN, Model Number 10094142

Siemens Medical Solutions USA, Inc

MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02

American Contract Systems Inc

DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110

Medtronic Perfusion Systems

Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product

ICU Medical Inc.

Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diagnostic use in the qu

Siemens Healthcare Diagnostics, Inc.

Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM AN

Medline Industries, LP

Signa 1.5T TwinSpeed Magnetic Resonance Imaging System

GE Healthcare, LLC

Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYN

Medline Industries, LP

Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FA

Cardinal Health 200, LLC

RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

Siemens Healthcare Diagnostics Inc

Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Baxter Healthcare Corporation

HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated; Article Numbers: 31207-10, 31207-12, 31

I.T.S. GmbH

LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500

MEDLINE INDUSTRIES, LP - Northfield

Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

Abbott Medical

SIGNA Premier magnetic resonance scanner, model 5748519.

GE Healthcare, LLC