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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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enGen (TM) Laboratory Automation System configured with Data Innovations, LLC Instrument Manager (TM...
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2
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06/02/2014
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Ortho-Clinical Diagnostics
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enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro ...
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2
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06/10/2014
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Ortho-Clinical Diagnostics
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enFlow IV Fluid Warmer Part number 980105VS;
(510K name: enFlow IV Fluid Warmer Model 100, EFlow Di...
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2
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08/19/2011
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Vital Signs Devices, a GE Healthcare Company
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enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL
100, EFLOW DISPOSABLE CARTRIDGE, MO...
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2
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07/09/2012
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Vital Signs Devices, a GE Healthcare Company
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embla Embletta Gold (It functions as a Polysomnography Recorder and Ventilator Effort Recorder).
...
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2
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06/11/2013
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Embla System Llc
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eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert...
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2
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10/02/2014
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Gendex Corp
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eSwallow Multi-Program Dysphagia Therapy Test unit
Intended Use: Powered Muscle Stimulator for t...
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2
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07/25/2011
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eSwallow USA LLC
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eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Arch...
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2
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10/15/2014
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Merge Healthcare, Inc.
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e.cam line of gamma camera systems
Used to detect or image the distribution of radionuclides in ...
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2
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10/22/2014
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Siemens Medical Solutions USA, Inc.
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e.cam camera system. Emission Computed Tomography System used to detect or image the distribution o...
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2
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07/11/2014
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Siemens Medical Solutions USA, Inc.
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