Day

November 27, 2013
Company: Carl Zeiss Meditec, Inc. Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians...
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Company: Carl Zeiss Meditec, Inc. Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians...
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Company: Spacelabs Healthcare, Llc Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment...
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Company:Philips Medical Systems North America Inc. Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT EPIQ 7 Ultrasound System, Model 795200, 795201, 795202. Intended for diagnostic ultrasound imaging and fluid flow analysis. Recall Number Z-0368-2014 REASON A problem has been detected with Philips Model EPIQ 7 Ultrasound System, software version 1.0 and 1.0.1. Using the International...
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Company: GE Healthcare, LLC Date of Enforcement Report:11/27/2013 Class ll: PRODUCT GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating...
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Company: GE Healthcare It Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially...
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http://mobihealthnews.com/27563/in-tense-hearing-congressman-declares-software-is-not-a-medical-device/
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Company: Siemens Healthcare Diagnostics Date of Enforcement Report: 11/27/2013 Class lI: PRODUCT ADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.Recall Number Z-0343-2014, Z-0344-2014, Z-0345-2014, Z-0346-2014 REASON iemens Healthcare Diagnostics issued a Urgent Medical Device Correction due to...
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