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U.S. Department of Health and Human Services

Medical Device Recalls

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Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension a... 2 Aug-30-2016 Medical Vision Ab
Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil Array for GE 1... 2 Aug-30-2016 Invivo Corporation
A7 Anesthesia Delivery System, a device used to administer to a patient, continuously or intermitten... 2 Aug-30-2016 Mindray DS USA, Inc. dba Mindray North America
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Catalog No. 775222 UniCel DxH Slide... 2 Aug-30-2016 Beckman Coulter Inc.
ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A... 2 Aug-30-2016 Siemens Healthcare Diagnostics, Inc.
HexaPOD evo RT System Product Usage: The intended use of the device is the control of accurate p... 2 Aug-30-2016 Elekta, Inc.
FUJIFILM Digital Mammography System Aspire HD (FDR MS-1000) with Biopsy Positioner (FDR-1000BPY) ... 2 Aug-30-2016 Fujifilm Medical Systems U.S.A., Inc.
INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. 2 Aug-29-2016 Integra LifeSciences Corp. d.b.a. Integra Pain Management
PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040... 2 Aug-29-2016 Philips Electronics North America Corporation
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting,... 2 Aug-29-2016 Teleflex Medical

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