BEUDAMED
    129 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Recall × Status: Terminated × Clear all

    Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope

    FDA Recall
    Terminated ·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016

    Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope

    FDA Recall
    Terminated ·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016

    Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope

    FDA Recall
    Terminated ·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016

    Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope

    FDA Recall
    Terminated ·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016

    Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope

    FDA Recall
    Terminated ·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016

    CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

    FDA Recall
    Terminated ·Philips Medical Systems Gmbh, DMC Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany·Product code JAA·December 19, 2019

    IMPAX Cardiovascular (CV) Reporting Reporting tool used for structured reporting and structured report outputs (including XML style sheet customization and PDF)

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·July 27, 2012

    Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code NWB·December 17, 2018

    The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are connected either directly or through networks. For use in a hospital environment. eCareManager allows clinicians to generate a PDF display of an order (new, change, discontinue), which is printed at the bedside and/or hospital pharmacy. This printed PDF should be reviewed by the clinician and verified by the hospital pharmacist and entered into the hospital pharmacy system.

    FDA Recall
    Terminated ·Visicu, Inc.·Product code MSX·March 27, 2015

    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

    FDA Recall
    Terminated ·Steris Corporation·Product code FLG·June 26, 2020

    CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.

    FDA Recall
    Terminated ·Medtronic Inc.·Product code PHV·August 5, 2016

    3D Ceiling Suspension

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IZF·April 15, 2003

    Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IZF·July 16, 2018

    Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IZF·July 16, 2018

    Giraffe Exam Light The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient light to facilitate performance of procedures on the mattress field. It is designed to mount on the accessory railings of the Giraffe OmniBed, incubators and warmers except for Panda and Giraffe Warmers. It is not intended for use to support surgical field lighting.

    FDA Recall
    Terminated ·Ohmeda Medical·Product code KZF·November 18, 2016

    All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 Model 100580 SGL Trolley, Serial No.''s less than TRS962633 Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.

    FDA Recall
    Terminated ·Burton Medical Products Corp·Product code KZF·February 19, 2004

    Stryker Visum 300 Ceiling-mounted Exam Light.

    FDA Recall
    Terminated ·Stryker Communications·Product code KZF·July 25, 2013

    Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code IZF·July 16, 2018

    Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated

    FDA Recall
    Terminated ·Stryker Communications·Product code KZF·April 21, 2017

    AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications

    FDA Recall
    Terminated ·Agfa N.V. Septestraat 27 Mortsel Belgium·Product code IZF·February 10, 2020