BEUDAMED
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    CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop: REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer: Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. by: Carestream Health, Inc., 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc·May 11, 2016

    CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop: REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer: Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. by: Carestream Health, Inc., 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States

    FDA Recall
    Terminated ·Carestream Health Inc·Product code LLZ·April 15, 2016

    System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA

    FDA Recall
    Terminated ·Custom Ultrasonics, Inc.·Product code KOG·February 11, 2008

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code JOY·May 2, 2016

    Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 22, 2016

    Post Medical Valves VO870A-Y and VO870-A-Y-T PSI 2015, PSI 2015, CGA 870, Inlet .750 STDS, Gas services (Oxygen), PSI 2015, Aluminum Cylinders, InterMed Gas Products LLC Industrial Division, 2056 Vista Parkway West Palm Beach, FL 33411.

    FDA Recall
    Terminated ·Intermed Gas Products Corporation·Product code ECX·March 27, 2009

    OptiMedica Catalys Precision Laser System, CE 0044 containing software cOS 5.00.33 Product Label for Serial Numbers: 44109015; 44106215; 44107315; and 44065613 label states "Manufactured for: OptiMedica Corporation 1310 Moffett Park Drive Sunnyvale, CA 94089 USA Product Label for Serial Numbers: 46120916; 46123116, 46124617; 46131418, and 46131618 label states "Manufactured for: OptiMedica Corporation 510 Cottonwood Drive Milpitas, CA 95035 USA The Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

    FDA Recall
    Terminated ·Johnson & Johnson Surgical Vision Inc·Product code OOE·May 9, 2018

    Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape. This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code NQN·May 6, 2016

    On Site Gas Systems POGS 33C Portable Oxygen Generation System

    FDA Recall
    Terminated ·On Site Gas Systems Inc.·Product code CAW·December 19, 2013

    On Site Gas Systems POGS 33C Portable Oxygen Generation System

    FDA Enforcement
    Class II ·Terminated·On Site Gas Systems Inc.·January 15, 2014

    MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only.

    FDA Enforcement
    Class II ·Terminated·Linde Gas North America Llc·June 26, 2013

    HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9016, Size (Fr) 16, # Eyelets 4, 10 per case

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008

    HydraGlide Heparin Coated PVC Right Angle Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9120, Size (Fr) 20, # Eyelets 4, 10 per case

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008

    HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9040, Size (Fr) 40, # Eyelets 6, 10 per case

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008

    HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9028, Size (Fr) 28, # Eyelets 6, 10 per case

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008

    ATP HydraGlide Trocar - Includes Tapered ATP Stylet, Atrium Code # 9420, Size (Fr) 20, # Eyelets 2, 10 per case

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008

    HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9036, Size (Fr) 36, # Eyelets 6, 10 per case

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008

    Argyle UVC Insertion Tray containing Safety Scalpel N11 (vendor part number 73-1811). Intended for use to insert an Umbilical Venous Catheter (UVC) into the umbilical artery or vein of neonate. Product Code: 43201

    FDA Recall
    Terminated ·Cardinal Health·Product code FOS·June 16, 2021

    GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery

    FDA Recall
    Terminated ·Surgical Instrument Service And Savings, Inc.·Product code GAS·May 3, 2013

    HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip, Atrium Code # 9012, Size (Fr) 12, # Eyelets 4, 10 per case

    FDA Recall
    Terminated ·Atrium Medical Corporation·Product code GBS·May 12, 2008