BEUDAMED
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    Agfa DX-D Imaging Package - (The detector power cables described in the Report of Correction and Removal are connected to portable detector panels used in the DX-D systems) Product Usage: DX-D Imaging Package ha the same intended use as the predicative devices: namely to provide diagnostic quality images to aid the physician with diagnosis. The device uses Agfas fla panel detectors with amorphous silicon scintillators and NX workstations with MUSICA imaeg processing to create radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The product is not indicated for use in mammography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code MQB·January 16, 2012

    AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.

    FDA Recall
    Terminated ·AGFA Corp.·Product code IZL·June 6, 2014

    AGFA DX-D 100 is a mobile digital radiography x-ray system

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code IZL·May 29, 2015

    DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

    FDA Recall
    Terminated ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code KPR·August 15, 2018

    AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts.

    FDA Recall
    Terminated ·AGFA Corp.·Product code IZL·May 15, 2013

    DX-D600 - DXD Imaging Package

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code KPR·May 2, 2016

    DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code KPR·July 2, 2014

    DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.

    FDA Recall
    Terminated ·Agfa-Gevaert, N.V. Prins Boudewijnlaan Kontich Belgium·Product code KPR·December 4, 2018

    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

    FDA Recall
    Terminated ·Howmedica Osteonics Corp.·Product code JWH·July 1, 2021

    Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.

    FDA Recall
    Terminated ·AGFA Healthcare Corp.·Product code IZL·May 13, 2014

    Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnostic implant that detects the onset of an ACS event and warns the patient to seek urgent medical care. The Guardian is an adjunct to patient recognized symptoms.

    FDA Recall
    Open, Classified ·Angel Medical Systems, Inc.·Product code QBI·September 1, 2023

    WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

    WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

    WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

    WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to provide vascular and transseptal access for the family of WATCHMAN FLX LAAC Devices with Delivery Systems.

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code DQY·July 29, 2025

    Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobile X-Ray modality, consisting of X-Ray console, generator, tube, digital detector, and workstation. This modality is used to generate projection X-Ray images of human patients. Models: 5411/ 050, A5411/ 0300 and A5411/ 0400

    FDA Recall
    Open, Classified ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code IZL·February 23, 2024

    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro quantitative determination of total homocysteine in human plasma or serum.

    FDA Recall
    Terminated ·Product code LPS·March 20, 2015

    Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A547ST; c) ST TOWEL CLAMPS NON PERFORATING (P/S), Product Code I68080; d) STERILE TOWEL CLAMPS 5 1/2, Product Code I68085; e) STERILE TOWEL CLAMPS 5 1/2", Product Code I68095; f) ZIPSER PENIS CLAMP STERILE (ZC110), Product Code ZC110ST

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code HXD·February 23, 2024

    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code MXD·March 30, 2026

    RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GXD·October 11, 2016