BEUDAMED
    96 results · 17ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Terminated × Clear all

    Brilliance iCT model #728306; Intended to produce cross- sectional images of the body.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 21, 2016

    Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 21, 2016

    Ingenuity Flex, model # 728317; Intended to produce cross- sectional images of the body.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 21, 2016

    Ingenuity Core, model # 728326; Intended to produce cross- sectional images of the body.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 21, 2016

    Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional images of the body.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 21, 2016

    Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.

    FDA Recall
    Terminated ·Philips North America, LLC·Product code MKJ·January 14, 2020

    Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four different configurations. Service tag numbers for these configurations are as follows: - 453564067151 24-Hour Configuration - 453564067161 48-Hour Configuration - 453564067171 96-Hour Configuration - 453564067181 7-Day Configuration Model Number: 860322

    FDA Recall
    Terminated ·Philips North America, LLC·Product code MWJ·January 13, 2020

    Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code JAK·June 22, 2020

    Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·September 4, 2018

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271540 FLEXIMA BILIARY FIRM 8F/35CM M001271550 FLEXIMA BILIARY FIRM 10F/35CM M001271560 FLEXIMA BILIARY REG 8F/35CM M001271570 FLEXIMA BILIARY REG 10F/35CM M001271580 FLEXIMA BILIARY REG 12F/35CM M001271590 FLEXIMA BILIARY REG 14F/35CM M001271600 FLEXIMA BILIARY SOFT 10F/35CM M001271610 FLEXIMA BILIARY SOFT 12F/35CM M001271620 FLEXIMA BILIARY SOFT 14F/35CM M001281560 FLEXIMA BILIARY 8/35 TT M001281570 FLEXIMA BILIARY 10/35 TT M001281580 FLEXIMA BILIARY 12/35 TT M001281590 FLEXIMA BILIARY 14/35 TT M001271630 FLEXIMA BIL 8F/35CM FIRM KIT M001271640 FLEXIMA BIL 10F/35CM FIRM KIT M001271650 FLEXIMA BIL 8F/35CM REG KIT M001271660 FLEXIMA BIL 10F/35CM REG KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFA·March 18, 2009

    Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·December 2, 2016

    AxSYM Quinidine Standard Calibrators - consist of six bottles of Cal A (6ml) and Cals B-F (4ml each)-Product List Number-7A73-01

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila·Product code LGI·May 31, 2007

    Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003

    ARCHITECT Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code CEC--·December 15, 2003

    BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I Product Usage: The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.

    FDA Recall
    Terminated ·Medtronic Perfusion Systems·Product code DWJ·February 8, 2018

    Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code DDG·June 9, 2022

    LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211 Product Usage:: Intravascular catheter

    FDA Recall
    Terminated ·Vygon Corporation·Product code LJS·April 26, 2011

    LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product Code 2296.214 Product Usage: Intravascular catheter

    FDA Recall
    Terminated ·Vygon Corporation·Product code LJS·April 26, 2011

    Calibration Serum Level 3 (CAL 3) - multi-analyte mixture calibrator. Catalogue Number: CAL2351

    FDA Recall
    Terminated ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JIX·March 29, 2021

    Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitrogen (BUN), and Uric Acid (UA) methods on the Dimension Vista System.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JIX·August 18, 2014