Day

May 21, 2014
Company Siemens Medical Solutions USA, Inc Date of Enforcement Report 5/21/2014 Class lI: PRODUCT Syngo Dynamics Product Usage: Syngo Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for...
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Company: SCC Soft Computer Date of Enforcement Report:5/21/2014 Class lI: PRODUCT SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory...
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Company: Nellcor Puritan Bennett Inc. (dba Covidien LP)Date of Enforcement Report:5/21/2014 Class lI: PRODUCT Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. Recall...
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Company: Codman & Shurtleff, Inc Date of Enforcement Report:5/21/2014 Class lI: PRODUCT MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Recall Number Z-1571-2014 REASON A...
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Company: Mckesson Medical ImagingDate of Enforcement Report:5/21/2014 Class lI: PRODUCT McKesson Radiology-PACS. McKesson Radiology is a medical image and information application that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems. Recall Number Z-1617-2014 REASON High priority alert...
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Company: CareFusion 303, Inc.Date of Enforcement Report:4/23/2014 Class I: PRODUCT Alaris Pump Module (Model 8100), Software Version 9.1.18 The Alaris Pump Model 8100 is a large volume infusion pump. It is intended for use in health care facilities that use infusion for the delivery of fluids, medicines, blood, and blood products using continuous or periodic...
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