September 26, 2012
Company:Zoll Medical Corp. Date of Enforcement Report 9/26/12 Class ll: PRODUCT Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In addition, the product may be used in synchronized...
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Company:SCC Soft Computer Date of Enforcement Report 9/26/12 Class ll: PRODUCT Product is SoftBank software (versions 21.4.2 to 23.0.0). Recall Number B-2337-12 REASON Software, with a glitch or defect, was distributed. RECALLING FIRM/MANUFACTURER SCC Soft Computer, Palm Harbor, FL on 2/23/2006. Voluntary: Firm Initiated recall has been terminated. VOLUME OF PRODUCT IN COMMERCE 10 units...
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Company:Haag-Streit USA Inc. Date of Enforcement Report 9/26/12 Class ll: PRODUCT Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees...
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Company:Philips Medical Systems (Cleveland) Inc. Date of Enforcement Report 9/26/12 Class lll: PRODUCT The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.Recall...
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Company:Roche Molecular Systems, Inc. Date of Enforcement Report 9/26/12 Class ll: PRODUCT Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System. Recall Number Z-2403-2012 REASON When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2...
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