BEUDAMED
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    Filters FDA Recall × Status: Terminated × Clear all

    Toshiba Aquilion ONE CT SystemTSX-301 A/2D

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·February 3, 2009

    TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display cross sectional volumes of the whole body, to include the head. The Aquilion RXL has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code JAK·October 1, 2013

    20mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC2000 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code LHI·April 4, 2013

    13mm addEASE(TM) Binary Connector with 17 Ga. Needle for use with PAB(R) Containers, BC1300 Product is intended for fluid transfer between a Partial Additive Bag (PAB(R)) container and a drug vial.

    FDA Recall
    Terminated ·B. Braun Medical, Inc.·Product code LHI·April 4, 2013

    Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0

    FDA Recall
    Terminated ·Cook Urological, Inc.·Product code EZN·January 22, 2003

    Pursuit ureteral dilation balloon catheters, 6 mm x 8 cm. Order # PAB-050080-6-8.0

    FDA Recall
    Terminated ·Cook Urological, Inc.·Product code EZN·January 22, 2003

    VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.

    FDA Recall
    Terminated ·Ventana Medical Systems Inc·Product code OWF·August 2, 2018

    Replacement LED PCB Kit, part number 001840, of the Natus neoBLUE (aka neoBLUE 2) Phototherapy system. Neonatal phototherapy.

    FDA Recall
    Terminated ·Natus Medical Incorporated·Product code LBI·November 19, 2014

    B. Braun addEASE Binary Connector, Catalogue #N7990, 200 units (50 units per bag with 4 bags per shipping box) Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.

    FDA Recall
    Terminated ·B. Braun Medical Inc·Product code LHI·June 24, 2010

    B. Braun addEASE Binary Connector, Catalogue #N7993, 200 units (50 units per bag with 4 bags per shipping box) Intended for use in a pharmacy setting to connect a B. Braun 250mL Excel IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.

    FDA Recall
    Terminated ·B. Braun Medical Inc·Product code LHI·June 24, 2010

    CELL-DYN Sapphire Probe Detector PCB Assembly (also called the Aspiration Bottom Sensor) used on the Cell-Dyn Sapphire Hematology Analyzer, Manufactured by Abbott Laboratories, Santa Clara, CA

    FDA Recall
    Terminated ·Abbott Laboratories·Product code GKZ·April 5, 2010

    Low Titer Type O FWB Transfusion Set (P/N 80-875 NSN 651501684994). Blood convenience kit. The Transfusion Set includes the items necessary to administer the collected blood to a patient.

    FDA Recall
    Terminated ·Combat Medical Systems, LLC·Product code POQ·December 23, 2020

    Integrated Gate Controller PCB (component of AlignRT Plus) Truebeam variant only. The AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. Part number: V000172

    FDA Recall
    Terminated ·Vision RT Ltd Dove House Arcadia Avenue London United Kingdom·Product code IYE·August 24, 2018

    Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal line pressure and signal when the pressure exceeds the operator-set limit.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWB·August 29, 2011

    Sony LMD-1951MD, Sony LMD1951MD/BS, Sony LMD-1951MC (Foreign) 19 inch medical grade liquid crystal display (LCD) Medical Monitors with light-emitting diode (LED) backlight technology.

    FDA Recall
    Terminated ·Sony Medical Systems·Product code FWB·January 13, 2015

    Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.

    FDA Recall
    Terminated ·Trumpf Medical Systems, Inc.·Product code FWB·December 15, 2017

    Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWB·October 21, 2011

    GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.

    FDA Recall
    Terminated ·GE OEC Medical Systems, Inc·Product code OXO·April 26, 2010

    CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7 The device is used to cover and protect wounds.

    FDA Recall
    Terminated ·Pharmaplast S.A.E. Free Zone Factory POB 37 Amria Free Zone Kafr El Zayat, Gharbia Egypt·Product code KGX·February 21, 2011