Day

September 25, 2013
HealthCanada released a FAQ sheet answering basic questions about software regulated as a medical device. The document clarifies that software regulated as a medical device is software which retrieves data from a medical device in order to aid or replace a physician’s decision regarding the diagnosis or treatment of a patient. Software that transmits data...
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Company: GE Healthcare, LLC Date of Enforcement Report: 9/25/2013 Class ll: PRODUCT GE Healthcare, Seno Advantage, 5183685, 5183685-2, 5183685-3, 5183685-4, 5183685-5, 5183685-6, 5183685-7, 5183685-8, 5183685-9, 5342425, 5342425-2, 5342425-3, 5342425-4, 5342425-5. Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis...
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Company: GE Healthcare, LLC Date of Enforcement Report: 9/25/2013 Class ll: PRODUCT GE Healthcare, Advantage Workstation, READY View Application. Image analysis software. Recall Number Z-2241-2013 REASON GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed. RECALLING FIRM/MANUFACTURER GE Healthcare,...
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Company: GE Healthcare, LLC Date of Enforcement Report: 9/25/2013 Class ll: PRODUCT GE Healthcare Discovery IGS 730 Cardiovascular X-Ray Imaging System. The angiography X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray...
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Company: GE Healthcare, LLC Date of Enforcement Report: 9/25/2013 Class ll: PRODUCT GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and...
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The FDA Safety and Innovation Act (FDASIA) workgroup completed its work and made its draft recommendations in September. The recommendations include: HIT should not be regulated except in cases where there is risk to the patient, a patient-safety risk framework should be used to allow application of regulatory oversight by risk, vendors should be required...
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Company: B Braun Medical, Inc. Date of Enforcement Report: 9/25/2013 Class l: PRODUCT Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative...
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