BEUDAMED
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    Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; MSO-01451-UCL; MTO-01451-RH; PL-05041; PR-04041-HPX; PR-05041; PR-05041-HP; PR- 05041-HPX; PR-05041-LW; PR-05041-MW; PR-05041-T; PR-05042; PR-05541-HPX; PR-07041-PTSP; and RJ-01451-W.

    FDA Recall
    Terminated ·Arrow International Inc·Product code LJS·March 29, 2010

    BRANSIST safire Product Usage: DIGITAL ANGIOGRAPHY SYSTEM This system is intended to be used for radiologic visualization of the heart, blood vessels or lymphatic system during or after injection of a contrast medium. It is to be used in the diagnosis of the circulatory vascular system while being combined with a positioning device and other devices.

    FDA Recall
    Terminated ·Shimadzu Medical Systems Usa Com·Product code IZI·January 14, 2019

    TRINIAS for diagnostic imaging and interventional procedures in cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Recall
    Terminated ·Shimadzu Medical Systems Usa Com·Product code OWB·January 14, 2019

    SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals

    FDA Recall
    Terminated ·Shimadzu Medical Systems Usa Com·Product code KPR·May 23, 2017

    SHIMADZU MobileDaRt Evolution (MX8 Version), Mobile X-Ray System Product Usage: This device is intended to be used to take a film, CR or general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. Exposure can be captured on film, CR or Digital Radiography (DR).

    FDA Recall
    Terminated ·Shimadzu Medical Systems Usa Com·Product code IZL·January 14, 2019

    TRINIAS Digital Angiographic System intended to be used for cardiac angiography, neurovascular angiography, abdominal angiography, peripheral angiography, rotational angiography, multi-purpose angiography and whole body radiographic/fluoroscopic procedures.

    FDA Recall
    Terminated ·Shimadzu Medical Systems Usa Com·Product code OWB·June 15, 2018

    SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number: CH-200/CH-200M Holds an x-ray tube unit and collimator combined with an z-ray high voltage generator, radiographic stand, and table. It is designed to perform radiography of patients either in a standing or supine position

    FDA Recall
    Terminated ·Shimadzu Medical Systems Usa Com·Product code KPR·May 23, 2017

    SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system

    FDA Recall
    Terminated ·Shimadzu Medical Systems Usa Com·Product code KPR·May 23, 2017

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Recall
    Terminated ·CHG Hospital Beds Inc 153 Towerline Place London Canada·Product code FNL·June 28, 2016

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Recall
    Terminated ·CHG Hospital Beds Inc 153 Towerline Place London Canada·Product code FNL·February 18, 2015

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Recall
    Terminated ·CHG Hospital Beds Inc 153 Towerline Place London Canada·Product code FNL·June 28, 2016

    Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.

    FDA Recall
    Terminated ·Dentech Corp. 53 Shimizu-Cho, Itabashi-Ku Tokyo Japan·Product code EEF·April 21, 2021

    UniCel DxC 660i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the DxI analyzers according to programming requirements. The UniCel DxC 600 or DxC 800 Synchron Clinical System is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid (sample type is chemistry dependent). The UniCel DxI 600 or DxI 800 Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, and qualitative determination of various analyte concentrations found in human bodily fluids.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEM·October 22, 2010

    VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code CEM·May 9, 2013

    ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600/800 Systems), Part No. A28937, A28945, 467935, 467915. Product Usage: ISE Electrolyte Buffer reagent and ISE Electrolyte Reference reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium concentration in human serum, plasma or urine.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEM·September 22, 2010

    QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with the QuikLYTE module. Intended Use of the QuikLYTE module : The Na+, K+, Cl and TCO2 methods on the Dimension clinical chemistry system with the QuikLYTE module are in vitro diagnostic tests intended for the quantitative measurement of sodium, potassium, chloride and total carbon dioxide in human serum and heparinized plasma. They are also intended for the quantitative measurement of Na+, K+ and Cl- in urine.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CEM·February 24, 2015

    ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

    FDA Recall
    Terminated ·Radiometer America Inc·Product code CEM·July 10, 2019

    EPOC BGE Test Card The EPOC Blood Analysis System is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of whole blood samples in the laboratory or at the point of care in hospitals, nursing homes, or other clinical care institutions. The Blood Gas Electrolyte (BGE) test card panel of this device includes sensors for testing Sodium, Potassium, ionized Calcium, pH, pCO2, pO2 and Hematocrit.

    FDA Recall
    Terminated ·Epocal·Product code CEM·October 16, 2008

    GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number 442640; SYNCHRON and UniCel Systems and Part Numbers: Synchron LX20, Part Number: 466200, Synchron LX20 PRO, Part Number: 476100, Synchron LXI 725, Part Number: 476501, UniCel DxC 600, Part Number: A10405, UniCel 600 PRO, Part Number: A11810, UniCel DxC 600i, Part Number: A27318, UniCel DxC 800, Part Number: A11816, UniCel DxC 800 PRO, Part Number: A11812, UniCel DxC 880i, Part Number: A59102, UniCel DxC 660i, Part Number: A64871, UniCel DxC 680i, Part Number: A64903, UniCel DxC860i, Part Number: A64935 (1) The Synchron LX and UniCel DxC Synchron Clinical Systems are fully automated, computer controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (Sample type is chemistry dependent). (2) GLUCm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEM·August 10, 2010

    UniCel DxC 880i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel DxI 600 or UniCel DxI 800 analyzer into a single instrument presentation. Samples are loaded from a single point of entry through a UCTA (UniCel Closed Tube Aliquotter). The UCTA functions as the sample processing manager by aliquotting and routing samples to the DxC and the DxI analyzers according to programming requirements. The UniCel DxC 600 or DxC 800 Synchron Clinical System is a fully automated, computer-controlled clinical chemistry analyzer intended for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries of clinical interest in biological fluids such as serum, plasma, urine, or cerebrospinal fluid (sample type is chemistry dependent). The UniCel DxI 600 or DxI 800 Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative, and qualitative determination of various analyte concentrations found in human bodily fluids.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEM·October 22, 2010