BEUDAMED
    26 results · 63ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.

    FDA Recall
    Terminated ·Shape Medical Systems, Inc·Product code BTY·December 23, 2014

    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.

    FDA Recall
    Terminated ·Shape Medical Systems, Inc·Product code BTY·May 28, 2014

    Varian brand Varian Clinac Accelerators with Mark, Millennium MLC 120 (Multileaf Collimator) and BrainLAB m3 MCL, Reference/FSCA CP-05591, Model Number: H53, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA Intended use: The Varian Millennium 120 Collimator (MLC) is an x-ray collimator designed to be mounted on a C or EX Series Varian Clinac radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac dose fraction or gantry angle. The intended use is to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·November 10, 2011

    XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00. Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed.

    FDA Recall
    Terminated ·Computerized Medical Systems Inc·Product code MUJ·December 9, 2008

    Siemens mMLC (ModuLeaf) safety bar and trolley label. Siemens Medical Solutions USA, Inc. Concord, CA. The intended use of the Siemens branded mMLC is an accessory used with the Linear Accelerator systems to deliver x-ray photon and electron radiation for the therapeutic treatment of cancer. This accessory shapes the radiation beam, per the leaf parameters, to minimize the amount of dose to outlying tissue.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IXI·February 7, 2012

    AMO brand WaveScan WaveFront System, OPM software versions 3.67 and 3.67, Part Number: 0070-1531, Catalog Numbers: 0070-1664,0070-1649,0070-1654: Version 3.67 0070-1721: Version 3.671 0070-1662: Version 3.67, US version; 0070-1668; IVersion 3.67 International version Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The WaveScan WaveFront System is a class III accessory device used in conjunction with the VISX STAR S4 and STAR S4 IRTM Excimer Laser Systems, which are indicated for wavefront-guided laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations. The WaveScan WaveFront System is a diagnostic instrument intended for the automated measurement, analysis, and recording of refractive errors of the eye. The WaveScan System software uses the diagnostic data of the eye's refractive errors and wavefront aberrations to calculate the target treatment shape and then generates the commands for the VISX STAR laser to create the target shape on the cornea.

    FDA Recall
    Terminated ·AMO Manufacturing USA, LLC·Product code LZS·July 13, 2010

    Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·May 6, 2011

    Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HSZ·May 6, 2011

    Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBE·May 6, 2011

    Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; Model Number(s): All models, including H52, H54, H56, HHM; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Multileaf Collimator is intended to assist the Radiation Oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·January 16, 2012

    Varian brand 52-leaf Millennium MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; All models, including H52, H54, H56, HHM; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Multileaf Collimator is intended to assist the Radiation Oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc. Oncology Systems·Product code IYE·January 16, 2012

    ***REF IMRI-MOTOR***iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBB·April 25, 2013

    Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

    FDA Recall
    Terminated ·RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden·Product code MUJ·May 9, 2012

    ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·April 25, 2013

    ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc. Intended for cutting and shaping bone.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code ERL·April 25, 2013

    ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HSZ·April 25, 2013

    Sterile Bone Cutting Burrs model M-6P labeled in part:***M-6P***QTY: 1***6 mm x 9 mm Fluted Pear.***Use with*** MEDIUM Attachments.***Use by 2015-12***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT D493042603***. Cutting and Shaping bone including bones of the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·May 9, 2011

    Sterile Bone Cutting Burrs model S-5B-4 labeled in part:***S-5B-4***QTY: 1***5 mm Fluted Ball, 4-Series.***Use with***SHORT Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT E173049623***. Cutting and Shaping bone including bones of the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·May 9, 2011

    Sterile Bone Cutting Burrs model QD8-4OVD labeled in part:***QD8-4OVD***QTY: 1***4 mm x 8 mm Diamond Oval. Use with***QD8 Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT E173049563***. Cutting and Shaping bone including bones of the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·May 9, 2011

    Sterile Bone Cutting Burrs model SIL-7-9 labeled in part:***SIL-7-9***QTY: 1***9 mm Fluted Ball.***Use with B-Silber***Attachment.***Use by 2015-01***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT D053031534***. Cutting and Shaping bone including bones of the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·May 9, 2011