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    iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1.87, and 4.1.92; Product is manufactured and distributed by Philips Medical Systems, Foster City, CA iSite PACS: iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code LLC·February 23, 2011

    iSite PACS with iSite ViewForum Applications, R7.4V6 L1 L2, L3, Versions: 3.6.96, 3.6.101, 3.6.110, 4.1.96, 4.1.101, and 4.1.110 ; Product is manufactured and distributed by Philips Medical Systems, Foster City, CA ViewForum Applications: iSite ViewForum Applications is an image processing workstation software package designed to run on standard PC hardware. The hardware required is made up of "off-the-shelf" standard computer components. iSite ViewForum Applications software receives image data from medical scanning devices, such as CT and MRI, or from image archives. iSite ViewForum Applications performs viewing, image manipulation, communication, printing, and quantification of images.

    FDA Recall
    Terminated ·Philips Medical Systems·Product code LLC·February 23, 2011

    POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.

    FDA Recall
    Terminated ·POM Medical LLC·Product code BYG·July 11, 2018

    Cell Search Circulating Tumor Cell Kit (Epithelial) Veridex LLC, a Johnson & Johnson Company IVD Veridex, LLC 33 Technology Drive Warren, NJ 07059 USA 1-877-VERIDEX USA

    FDA Recall
    Terminated ·Veridex, LLC·Product code NQI·April 17, 2007

    CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance.

    FDA Recall
    Terminated ·iCAD, Inc.·Product code LNH·December 9, 2008

    Sodium Chloride Injection USP, manufactured by IV Flush LLC

    FDA Recall
    Terminated ·IV Flush LLC·Product code FOZ·January 26, 2005

    Heparin Lock Flush Solution, manufactured by IV Flush LLC

    FDA Recall
    Terminated ·IV Flush LLC·Product code FOZ·January 26, 2005

    Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400

    FDA Recall
    Terminated ·QiG Group LLC·Product code LGW·January 26, 2016

    CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

    FDA Recall
    Terminated ·CoreLink LLC·Product code MAX·October 20, 2022

    Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.

    FDA Recall
    Terminated ·Airways Development LLC·Product code BYE·September 24, 2015

    Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100

    FDA Recall
    Terminated ·Medela Inc·Product code FMF·December 5, 2018

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

    FDA Recall
    Terminated ·QiG Group LLC·Product code LGW·January 26, 2016

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)

    FDA Recall
    Terminated ·QiG Group LLC·Product code LGW·January 26, 2016

    SHARP MEDICAL PRODUCTS, LLC Reactor and Sleeve REF 100-36-01 Size: Adult

    FDA Recall
    Terminated ·Sharp Medical Products·Product code GCJ·February 8, 2021

    Sterile empty vials, 10mL/20mm closure sold 25/case. Label on vial states STERILE EMPTY VIAL Hollister-Stier Laboratories LLC Spokane, WA 99207 USA . Labels on case states 25 STERILE EMPTY VIALS 10 mL/20mm Closure CAUTION: For manufacturing, Processing or Repacking Rx only NON-RETURNABLE LOT Hollister-Stier Laboratories LLC Spokane, WA 99207

    FDA Recall
    Terminated ·Hollister Stier Laboratories LLC·Product code LDH·April 20, 2006

    f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065.

    FDA Recall
    Terminated ·Mainline Technology, Inc.·Product code JHI·August 18, 2008

    2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.

    FDA Recall
    Terminated ·Omega Medical Imaging, Inc.·Product code N/A·June 21, 2016

    Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuStar; and Pelton & Crane. Part number for the bolt: 022R065 Product is labeled in part: DCI Equipment, Mfg By: Dental Equipment, LLC. DC1235, Marus Dental, Mfg By: Dental Equipment, LLC. DC1490, DC1690, and DC1700, and DC1702, Pelton & Crane, Spirit SP17.

    FDA Recall
    Terminated ·Dental Equipment LLC·Product code NRU·March 1, 2011

    Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.

    FDA Recall
    Terminated ·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code CBK·October 1, 2014

    Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.

    FDA Recall
    Terminated ·ROi CPS LLC·Product code MLS·October 12, 2020