Medical Device Recalls

Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143

Philips North America Llc

BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZ

Hologic, Inc

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A

MEDLINE INDUSTRIES, LP - Northfield

VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a

Ortho-Clinical Diagnostics, Inc.

GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:

GE Healthcare (China) Co., Ltd.

BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03,

CareFusion 303, Inc.

ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320;

Sklar Instruments

NanoSight NS300

MALVERN PANALYTICAL LTD

ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.

Olympus Corporation of the Americas

Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F

Boston Scientific Corporation

DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.

Philips North America Llc

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (C

Philips North America Llc

FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

BioFire Diagnostics, LLC

GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3)

GE Medical Systems, LLC

Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Softwar

Spacelabs Healthcare, Inc.

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 78

UIH Technologies LLC

A.L.P.S. mvX- Product Name: ANATOMIC LAT FIB PLATE 10H LT Anatomic Lateral Fibula Plate, 10-Hole, Left. Intended Fixati

Tyber Medical

a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDI

Smiths Medical ASD Inc.

Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Ve

Siemens Medical Solutions USA, Inc

PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851

Biomerieux Inc

Medline procedure packs containing Shenli syringes, labeled as follows: 1) NEURO ANGIO PACK, Part Number DYNDA1431A;

MEDLINE INDUSTRIES, LP - Northfield

Single Shot Epidural Tray Catalog Number: 8417

Busse Hospital Disposables, Inc.

Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to p

Baxter Healthcare Corporation

GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300

Biomerieux Inc

Luminos Agile Max (VE10, VF10, VF11)

Siemens Medical Solutions USA, Inc

EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, s

Olympus Corporation of the Americas

Software VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation and digital processing of medic

PTW-FREIBURG

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter

Boston Scientific Corporation