Medical Device Recalls

Pollen Allergy Test

GET TESTED INTERNATIONAL AB

Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only

UIH Technologies LLC

DigitalDiagnost 4 High Performance. radiography and fluoroscopy system

Philips Medical Systems DMC GmbH

Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only

Abbott Medical

Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07

AVID Medical, Inc.

RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8

RAYSEARCH LABORATORIES AB

BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673

Becton Dickinson & Co.

Servo-u Ventilator System. Model Number: 6688600.

Maquet Critical Care AB

nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR r

Landauer

LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11

Linkbio Corp.

Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm

Stryker, Inc.

COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number

Cook Incorporated

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