BEUDAMED
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    UniCel DxC 880i, 860i,680i and 660i Synchron Access Clinical Systems The Unicel DxC Integrated Workstation takes samples 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 Dxl analyzers according to the programming requirements

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code LIG·May 7, 2009

    ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories MPG·Product code LIG·March 8, 2006

    ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code LIG·August 19, 2004

    3 Liter Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720057B, Medline Item Number: 40053; Available in various Anesthesia Circuit Kits and Complete Delivery System Kits including: 1) Item Number DYNJ09422, Anesthesia Kit-LF; 2) Item Number DYNJAA9010A, Anesthesia Circuit Adult Expand; 3) Item Number 00-GS2675K, Pacemaker Kit; 4) Item Number ACC010004A, Anesthesia Drawer 6; 5) Item Number ACC010015, Anesthesia Drawer 8; 6) Item Number ACC010015A, Anesthesia Drawer 8; 7) Item Number ACC010031, Anesthesia Case Cart Drawer 6; 8) Item Number ACC010036, Anesthesia Drawer 6; 9) Item Number ACC010056, Anesthesia Cart Drawer 6; 10) Item Number CDS760048M, D&C CDS; 11) Item Number CDS760050L, Vag Hyster CDS; 12) Item Number CDS760054F, Laparoscopy CDS; 13) Item Number CDS780080J, Major Spinal CDS; 14) Item Number CDS780081G, Minor Spine CDS-LF; 15) Item Number CDS780127C, Lumbar CDS; 16) Item Number CDS780150A, Craniotomy CDS-LF; 17) Item Number CDS780151A, Spinallami-Fusion-Disk-Lumb-LF; 18) Item Number CDS840144B, Open Heart CDS; 19) Item Number CDS840270C, Carotid CDS; 20) Item Number CDS840325B, Major Vascular CDS; 21) Item Number CDS840336A, Heart-LF; 22) Item Number CDS840337A, Vascular Minor CDS-LF; 23) Item Number CDS840338A, Carotid Endarectomy CDS-LF; 24) Item Number CDS840384A, Open Heart CDS; 25) Item Number CDS840429, Arrowhead Open Heart CDS; 26) Item Number CDS840463A, Accessory Pack; 27) Item Number CDS840494, AV Fistula CDS; 28) Item Number CDS860094C, Laparoscopic Colon Resection; 29) Item Number CDS860109A, Laparoscop Bilat Tubal Lig-LF; 30) Item Number CDS860159, Major ABD Procedure CDS-Pack A; 31) Item Number CDS860159A, Major ABD Procedure CDS; 32) Item Number CDS860160A, Minor ABD Procedure CDS; 33) Item Number CDS860161, Lithotomy Major CDS; 34) Item Number CDS860161A, Lithotomy Major CDS; 35) Item Number CDS860200, Lap Appy Kit; 36) Item Number CDS860200A, Lap Appy Kit; 37) Item Number CDS860201, Lap Chole Kit; 38) Item Number CDS860201A, Lap Chole Kit; 39) Item Number CDS860202, Lap Nissen Kit; 40) Item Number CDS860202A, Lap Nissen Kit; 41) Item Number CDS920108C, Laparoscopy CDS; 42) Item Number CDS930145C, Lap Chole CDS; 43) Item Number CDS930178F, Lap Chole Somc CDS-LF; 44) Item Number CDS930183A, Lap Chole CDS-LF; 45) Item Number CDS930208B, Lap Chole CDS; 46) Item Number CDS940836B, Shoulder CDS; 47) Item Number CDS940836C, Shoulder CDS; 48) Item Number CDS940837B, Knee CDS; 49) Item Number CDS940844C, Shoulder Arthroscopy CDS; 50) Item Number CDS940859C, Arthroscopy CDS-LF; 51) Item Number CDS940896F, Arthroscopy CDS; 52) Item Number CDS940900F, Shoulder CDS; 53) Item Number CDS941067A, Knee Replacement Total-LF; 54) Item Number CDS941068B, Total Hip CDS-LF; 55) Item Number CDS941248, Extremity Ortho CDS; 56) Item Number CDS941248A, Extremity Ortho CDS; 57) Item Number CDS941325, Dr Zeegan Total Hip Encino; 58) Item Number CDS941326, Dr Zeegan Total Hip Encino; 59) Item Number CDS980153B, Basic CDS; 60) Item Number CDS980211C, O.R. Turnover Kit; 61) Item Number CDS980228K, Breast Biopsy CDS; 62) Item Number CDS980232L, Plastic CDS; 63) Item Number CDS980395, D&C/Vaginal Minor CDS-LF; 64) Item Number CDS980510D, Neuro Associates Laminectomy; 65) Item Number CDS980701, Shoulder Arthroscopy Procedure; 66) Item Number CDS980702, Knee Arthroscopy Procedure; 67) Item Number CDS980703, Extremity Procedure; 68) Item Number CDS980704, Spine Procedure; 69) Item Number CDS980749, Minor CDS; 70) Item Number CDS980794, Lithotomy CDS; 71) Item Number CDS980796, Knee Arthroscopy CDS; 72) Item Number CDS980797, Gyn Abd CDS; 73) Item Number CDS980798, C-Section CDS; 74) Item Number CDS980799, Lap Chole CDS; 75) Item Number CDS980800, Hand CDS-Dr Casey; 76) Item Number CDS980801A, Lap Gastric CDS; 77) Item Number CDS980817, Total Hip CDS; 78) Item Number CDS980818, AV Fistula CDS; 79) Item Number CDS980819, Knee Arthroscopy CDS; 80) Item Number CDS980820, Shoulder Arthroscopy CDS; 81) Item Number CDS980821

    FDA Recall
    Terminated ·Medline Industries Inc·Product code BTC·December 7, 2007

    Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 2, 2014

    Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System & Brilliance CT Big Bore Radiology Whole Body Computed Tomography X-Ray System. Product Usage: The Brilliance CT Big Bore is a Whole Body Computed Tomography X-Ray System which produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·December 19, 2013

    Big Bore Radiology tomography X-ray system scanner, model number 728244. The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 6, 2016

    Big Bore Oncology tomography X-ray system scanner, model number 728243. The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 6, 2016

    GEMINI TF Big Bore computer tomograph software version 3.6. Catalog #882476, Gantry S/N 9001-9023. The GEMINI TF Big Bore is a diagnostic imaging systems for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·August 5, 2009

    Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 23, 2014

    Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 30, 2013

    GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 5, 2013

    Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·December 16, 2015

    Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 23, 2013

    GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare System, Cleveland, OH

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 19, 2014

    GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: 882476. A diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 16, 2014

    Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 29, 2014

    GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 29, 2015

    Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·December 4, 2013