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    Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS / IntelliSpace PACS DCX receives digital images and data from various sources (including but not limited to CT, MR, US, NM, XA, RF, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Typical users of the MDC PACS /IntelliSpace PACS DCX and DIAGNET are trained medical professionals, including but not limited to radiologists, clinicians. technologist and others

    FDA Recall
    Terminated ·Philips Medical Systems, Inc.·Product code LLZ·April 2, 2014

    ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment.

    FDA Recall
    Terminated ·MDC Acquisition Co.·Product code FPS·April 23, 2010

    MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code LLZ·September 1, 2011

    Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the control unit component, Article #10448446, in combination with a Leica M822 Optics Carrier-XY-Focus-Tilt-Unit, article #10448587; Leica Microsystems (Schweiz) AG, Max Schmidheiny-Strasse 201, CH-9425, Heerbrugg, Switzerland The intended use of the microscope is for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.

    FDA Recall
    Terminated ·Leica Microsystems, Inc.·Product code ETP·December 21, 2011

    All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 100-240V 50/60 Hz, 600 VA MOD - Affinity 30 GMDN - 40761 100-240V 50/60 Hz, 450 VA MOD - Affinity 50 GMDN - 40761 100-240V 50/60 Hz, 450 VA MOD - Affinity 70 GMDN - 40761 100-240V 50/60 Hz, 450 VA

    FDA Recall
    Terminated ·Philips Ultrasound Inc·Product code IYN·October 27, 2020

    Philips EPIQ Diagnostic Ultrasound System; Model Numbers: EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 7G, EPIQ 7C, EPIQ CVx & EPIQ CVxi. MOD EPIQ Elite DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only 100-240V~50/60 Hz, 600 VA MOD EPIQ 5 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM; GMDN 40761, Rx Only, 100-240V~50/60 Hz, 600VA MOD EPIQ DIAGNOSTIC ULTRASOUND SYSTEM; Rx Only,100-240V~50/60 Hz, 600VA

    FDA Recall
    Terminated ·Philips Ultrasound Inc·Product code IYN·December 16, 2020

    EPIQ DIAGNOSTIC ULTRASOUND SYSTEM, Model EPIQ 5C, EPIC 5G, EPIQ 5W, EPIQ 7C, EPIC 7GC, and EPIQ 7W. Diagnostic Ultrasound System for ultrasound imaging in abdominal, cardiac adult, cardiac other (fetal), cardiac pediatric, cerebral vascular, cephalic (adult), cephalic (neonatal), fetal/obstetric, gynecological, intraoperative (vascular), intraoperative (cardiac), musculoskeletal (conventional), musculoskeletal (superficial), other: urology, pediatric, peripheral vessel, small organ (breast, thyroid, testicle), transesophageal (cardiac), trans rectal, transvaginal.

    FDA Recall
    Terminated ·Philips Ultrasound, Inc.·Product code IYN·March 28, 2016

    ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping bone including spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·April 13, 2015

    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use.

    FDA Recall
    Terminated ·Owens & Minor Distribution, Inc.·Product code KGX·November 17, 2015

    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.

    FDA Recall
    Terminated ·Owens & Minor Distribution, Inc.·Product code KGX·November 17, 2015

    MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging] General Hospital Use.

    FDA Recall
    Terminated ·Owens & Minor Distribution, Inc.·Product code KGX·November 17, 2015

    ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible positioning for surgical procedures.

    FDA Recall
    Terminated ·Steris Corp·Product code GDC·April 17, 2009

    A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus sold under the CareFusion, Teleflex Medical, Symmetry Surgical brand names. A uterine tenaculum is a hook-like instrument used to seize and hold the cervix or fundus.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HDC·September 8, 2014

    OPERON D850 Surgical Table Product Usage: Surgical Table

    FDA Recall
    Terminated ·Berchtold Corp.·Product code GDC·April 16, 2012

    GYNDisposables Inc, IUD INSERTION KIT 935K, STERILE, SINGLE USE, Tenaculum 356T, Uterine Sound 906S, Scissors, Povidone-Iodine Solution, (3) Swabsticks, Paper Towel, STERILE EO, REF 935K, QTY 1, GYN Disposables,Inc. 2671 Appling Road, Memphis, TN 38133, ph 901.377.2200, fx 901.377.2207 Intended for intrauterine device (IUD) insertion.

    FDA Recall
    Terminated ·GYN Disposables Inc·Product code HDC·July 29, 2011

    The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.

    FDA Recall
    Terminated ·Steris Corporation·Product code GDC·October 10, 2014

    Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables

    FDA Recall
    Terminated ·Berchtold Corp.·Product code GDC·March 12, 2013

    STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. It accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The 5085SRT table is a variation of the 5085 table that enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).

    FDA Recall
    Terminated ·Steris Corporation·Product code GDC·April 6, 2012

    Operon Electrical Operating Room Table. The device is used as an electrical operating room table.

    FDA Recall
    Terminated ·Berchtold Corp.·Product code GDC·February 2, 2009

    Mizuho OSI Trios, Table Base; Voltage: 100-240V ~ 50/60 Hz Amps: 5,0-5.0A; Model 7803 and 7803AP Orthopaedic: Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.

    FDA Recall
    Terminated ·Mizuho OSI·Product code GDC·December 14, 2015