BEUDAMED
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    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2020

    Drystar Mammo. Display of Mammographic images.

    FDA Recall
    Terminated ·AGFA Corp.·Product code IWZ·March 2, 2010

    SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12. SoftPath is a laboratory information system to be used in a clinical laboratory by knowledgeable, trained, and experienced personnel. SoftPath enables the user to document steps in the receiving and processing of surgical, gynecological, medical cytological, and autopsy case specimens within the Pathology labs, for the purpose of generating Pathology reports for requesting physicians and label creation for identification of specimen/case material.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·June 13, 2011

    VITROS 5600 Integrated Systems, Catalog # 6802413; COMMON/USUAL NAME: VITROS 5600 --- NOTE: VITROS 5600 that are e-Connected are not affected by this issue. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·April 13, 2011

    VITROS 3600 Immunodiagnostics Systems, Catalog # 6802783; COMMON/USUAL NAME: VITROS 3600 --- NOTE: VITROS 3600 that are e-Connected are not affected by this issue. Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·April 13, 2011

    VITROS Chemistry Products DT Calibrator Kit, REF/Catalog No. 195 7927, IVD --- Common/Usual Name: VITROS DT Calibrator Kit -- Ortho-Clinical Diagnostics, Inc. Rochester, NY -- Ortho-Clinical Diagnostics High Wycombe, UK VITROS Chemistry Products DT Calibrator Kit is an in vitro diagnostic specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JIX·October 13, 2011

    IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and nonunions of the small bones and joints of the foot, ankle, hand and wrist.

    FDA Recall
    Terminated ·Extremity Medical LLC·Product code HWC·April 13, 2011

    Norco Shoulder Pulley Distributed by North Coast Medical, Gilroy, CA. Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery.

    FDA Recall
    Terminated ·North Coast Medical Inc 8100 Camino Arroyo·Product code ION·July 11, 2011

    Fresenius 2008T Hemodialysis Machine Part Number 190573, 2008T Hemodialysis System, OLCIDIASAFE PLUS Part Number 190713, 2008T Hemodialysis System with CDX Part Number 190766, 2008T Hemodialysis System with biBag The Fresenius 2008T is indicated for acute and chronic dialysis therapy.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·January 19, 2011

    Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above To create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·January 13, 2011

    LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes.

    FDA Recall
    Terminated ·Greiner Bio-One North America, Inc.·Product code JKA·December 14, 2011

    SARNS INTRACARDIAC SUCKER, BULK, NON-STERILE

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DTS·September 13, 2011

    XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs. Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018.

    FDA Recall
    Terminated ·Vitrolife, Inc.·Product code MSB·May 12, 2011

    Flexible Probe with Blocking Washer (part of Segmented Cylinder Set) The Segmented Cylinder Applicator Set was developed to treat cancer of the vagina, vaginal stump and rectum.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011

    Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by: Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determination of Cyclosporine in whole blood, using automated clinical analyzers as an aid in management of therapy in kidney, liver, and heart transplants

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code MKW·August 13, 2010

    INTRABEAM Shielding Material Flat 20 x 20 cm, Sterile/FO 0.05 mm Pb Equivalent (50keV) Carl Zeiss Meditec AG Indicated for radiation therapy treatments.

    FDA Recall
    Terminated ·Carl Zeiss Meditec, Inc.·Product code JAD·July 1, 2011

    Clinac iX, 23EX, CX, DHXC, Novalis Tx, Trilogy and TrueBeam Linear Accelerators Drive Stands Indicated for sterostatic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·May 13, 2011

    Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·September 13, 2011

    Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·January 13, 2011

    Titanium Fletcher-style Applicator Set - Defined Geometry - CT Compatible with Titanium intrauterine probe with stopper length 40 mm, 30 degree angle. Varian Medical Systems, Palo Alto, CA; Manufactured by Varian Medical Systems Haan GmbH, Haan, Germany. To treat cancer of the uterus, cervix, endometrium and vagina.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code JAQ·July 13, 2011