Medical Device Recalls

Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

BVI CustomEyes Procedure Packs containing Sol-M Luer Lock and Luer Slip 1ml syringes, Part Number: 58001174;

Beaver Visitec International, Inc.

Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;

Adept Medical Ltd

AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent Sys

Boston Scientific Corporation

Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system

Medtronic MiniMed

2 in 1 Trichomonas / Gardnerella Test

GET TESTED INTERNATIONAL AB

ARTIS icono floor. Model Number: 11327700.

Siemens Medical Solutions USA, Inc

Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

Medica Corporation

Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D

Cardinal Health 200, LLC

GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD

GE Healthcare (China) Co., Ltd.

Azurion 5 M12 System Code: (1) 722227 (2) 722231

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

GE Healthcare Vivid S70N, ultrasound device

GE Vingmed Ultrasound As

Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG

Withings

Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silico

DSAART LLC

FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

BioFire Diagnostics, LLC

B125M Patient Monitor, REF 6160000-004-XXXXXX

GE Medical Systems, LLC

Article No. NA6050411, Valiant PhD No. 1 Econo

Ivoclar Vivadent, Inc.

Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085

Omega Medical Imaging, Inc.

Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product De

THOR Photomedicine Ltd

Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065

TELEFLEX LLC

Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device M

Philips North America Llc

Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.

Abbott Laboratories

Hobbs Medical Grasping Forceps Catalog Number: 5008

Hobbs Medical, Inc.

ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central veno

ZOLL Circulation, Inc.

MISHA Knee System Implant Small, Left, REF: 2-1001. MISHA Knee System Implant Small, Right, REF: 2-1002.

Moximed, Inc.

Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access overtube.

Trokamed GmbH

RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.

RAYSEARCH LABORATORIES AB

Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system

Philips North America Llc

Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W

MEDLINE INDUSTRIES, LP - Northfield

SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R

Siemens Medical Solutions USA, Inc.