July 11, 2012
Company:Philips Healthcare IncDate of Enforcement Report 7/11/12 Class ll: PRODUCT Philips Xcelera Connect, Software R2.1 L 1 SP2, an interface engine for data exchange. Philips Xcelera Connect R2.x is a generic interface and data mapping engine between a Hospital Information System (HIS), Imaging Modalities, Xcelera PACS and Xcelera Cath Lab Manager (CLM). This interface engine...
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Company:Maquet Medical Systems USA Date of Enforcement Report 6/18/12 Date Recall Initiated: February 20, 2012 Class l: PRODUCT FLOW-i Anesthesia System (software) REASON A technical alarm may be generated on the FLOW-i system when using the Manual/Automatic (MAN/AUTO) switch to change ventilation modes from manual to automatic or from automatic to manual if the switch...
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FDA released a new guidance dated July 3, 2012 entitled ” Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions. This guidance discusses types of Computer Aided Detection devices (CADe) and appropriate clinical data to include in 510(k)s and...
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The link provided is to the Official US Government Web Site for the Medicare and Medicaid Electronic Health Records (EHR) Incentive Programs. The terms EHR and Electronic Medical Record(EMR) are sometimes used interchangeably. The issue of what systems FDA does now or might in the future regulate as a medical device is not addressed via...
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