BEUDAMED
    52 results · 13ms · 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

    RayStation standalone software treatment planning system, Model No. 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, 9.0, 9.1, 9.2, 10.0 - Product Usage: RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments. The system functionality can be configured based on user needs.

    FDA Recall
    Terminated ·RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden·Product code MUJ·October 8, 2020

    Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·January 3, 2018

    Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·January 3, 2018

    Radiation Therapy Treatment Planning System, Model 5.0

    FDA Recall
    Terminated ·RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden·Product code MUJ·May 30, 2016

    TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

    FDA Recall
    Terminated ·American Optisurgical Inc·Product code LFL·April 30, 2013

    Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OJH·January 21, 2020

    NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    FDA Recall
    Terminated ·In2Bones, SAS 28 Chemin du petit Bois Ecully France·Product code HRS·December 19, 2016

    SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    FDA Recall
    Terminated ·In2Bones, SAS 28 Chemin du petit Bois Ecully France·Product code HRS·December 19, 2016

    CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code MOI·March 4, 2003

    GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code KOI·April 9, 2014

    CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (human) prepared in TRIS buffer with protein (bovine) stabilizers to yield the following assay values (U/ml): Control L - 35 and Control H - 150; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code MOI·June 9, 2006

    cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OOI·April 1, 2013

    IMMULITE /IMMULITE 1000 BR-MA (CA15-3)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code MOI·January 2, 2018

    ST-AIA PACK 27.29; Part Number: 025202 Assay, Tumor Marker

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code MOI·March 5, 2018

    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·November 17, 2021

    Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas CT/NG 4800 System, for in vitro diagnostics.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code OOI·March 1, 2013

    ARIES System and ARIES M1 System

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·April 19, 2017

    AxSYM CA 15-3 Reagent Pack; list 03B42; 100 test pack; an in vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories·Product code MOI·April 23, 2007

    Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic acid sequences; Abbott Molecular Inc., Des Plaines, IL 60018 USA; catalog #09K15-01 The Abbott m2000rt System provides for real-time measurement of the stages of the polymerase chain reaction (PCR). Real-time PCR measures PCR amplification as it occurs, cycle-by-cycle, allowing quantitative measurements to be made during the highly reproducible exponential phase of PCR.

    FDA Recall
    Terminated ·Abbott Molecular·Product code OOI·September 8, 2011

    Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay for CA 27.29 The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage III breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc·Product code MOI·March 8, 2017