BEUDAMED
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    ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code NIG·May 30, 2012

    ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·July 4, 2012

    Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FI; ProSpeed FII; ProSpeed EII; CT HiSpeed Series.

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code IXR·October 21, 2004

    Sonesta 6210 Fluoroscopy Procedure Table; a motorized procedure table with adjustments (via a remote control) for height, tilt, back and seat cushion position; Stille Surgical AB, Sundbybergsvagen 1A, SE-17173 Solna, Sweden

    FDA Recall
    Terminated ·Stille AB Gardsvagen·Product code IXR·August 27, 2008

    Rapid Response HUT (Head Up Tilt) Table. Model 1117. Powered electrophysiology tilt table with single drop section. Table that can tilt -15 degrees to 90 degrees (Trendelenburg). Medical Positioning Incorporated.800-593-3246. Used in clinical and hospital settings by trained radiologists.

    FDA Recall
    Terminated ·Medical Positioning Inc·Product code IXR·February 1, 2010

    Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code IXR·February 6, 2017

    Philips Easy Diagnost X-Ray System

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IXR·July 23, 2007

    Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code IXR·July 11, 2012

    UroDiagnost; x-ray system. Product Code: 708033

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IXR·July 19, 2016

    708033 URODiagnost As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Recall
    Terminated ·Philips Medical Systems Nederlands Veenpluis 4-6 Best Netherlands·Product code IXR·March 26, 2018

    Advantx Legacy Radiographic and Fluoroscopic systems, model 2102424, 2118104, 2157009, 2183000, 2206038, 2206048, 2206056, 2224559, 2258627, 2268730, 2330340, 2333974, 2118104-2, 2118104-3, 2118104-4, 2118104-5, 2118104-6, 2118104-7, 2118104-8, 2139574-2, 2147592-13, 2171204-2, 46-262751G6, 46-262751G7, 46-262751G8, 46-275382G58, and 46-302056G1. GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy.

    FDA Recall
    Terminated ·GE Healthcare·Product code IXR·January 2, 2008

    UroDiagnost Eleva, system code 708033

    FDA Recall
    Terminated ·Philips North America, LLC·Product code IXR·December 30, 2019

    Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code IXR·May 11, 2012

    Stille Sonesta Video Fluoroscopy Table 6210; manufactured by Stille AB, Solna, Sweden.

    FDA Recall
    Terminated ·Stille-Sonesta, Inc·Product code IXR·November 9, 2006

    Easy Diagnost DSI is a Easy Diagnost Digital Spot Imaging system. It has a capability to create digital images from an analog system. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IXR·January 4, 2008

    Rapid Response HUT (Head Up Tilt) Table. Model 1217. Powered electrophysiology tilt table with dual 2 way drop section. Table that can tilt -15 degree to 90 degree (Trendelenburg). Medical Positioning Incorporated. 800-593-3246. Used in clinical and hospital settings by trained radiologists.

    FDA Recall
    Terminated ·Medical Positioning Inc·Product code IXR·February 1, 2010

    X-Ray Diagnostic Table, Model No. YSF-300 Use in combination with an X-ray high voltage generator, an X-ray tube unit, an Image intensifier and X-ray television unit, this table is applied for the following X-ray examinations: -X-ray T.V. fluoroscopy -Spot-filming -Bucky radiography

    FDA Recall
    Terminated ·Shimadzu Medical Systems·Product code IXR·March 31, 2016

    EasyDiagnost Classic has a radiographic tilting table. This system has a cassette film option and it does not have a Digital Spot Imaging (DSI) system. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.

    FDA Recall
    Terminated ·Philips Medical Systems North America Co. Phillips·Product code IXR·January 4, 2008

    Foot Controls impacted for the following devices: OAKWORKS Medical CFPM 300 Imaging Table OAKWORKS Medical CFPM 301 Imaging Table OAKWORKS Medical CFPM 400 Imaging Table OAKWORKS Medical CFPM 401 Imaging Table OAKWORKS Medical CFPMB 301 Bariatric Imaging Table OAKWORKS Medical CFUR 301 Urology Table OAKWORKS Medical CFUR 401 Urology Table OAKWORKS Medical CFLU 401 Lithotripsy/Urology Table

    FDA Recall
    Terminated ·Oakworks Inc·Product code IXR·July 31, 2017

    Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition cystography Cystoscopy, endopscopy Transurethral resection Percutaneous nephroscopy Urethrorenoscopy Percutaneous nephrolithotomy Serial angiography with image intensifier and DSI Tomography

    FDA Recall
    Terminated ·Philips North America, LLC·Product code IXR·February 28, 2019