Company:ZOLL Medical Corp. Date of Enforcement Report 6/1/2011 Class ll: PRODUCT Zoll E Series BLS Defibrillator/Pacemaker/Monitor Software versions 7.10 and 7.11. 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...Read More

Company:Siemens Medical Solutions USA, Inc. Date of Enforcement Report 6/1/2011 Class ll: PRODUCT LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Electronic patient records management system. Model Product Number LANTIS COMMANDER 4503178 LANTIS System 5835991 LANTIS Commander 6.1 5493072 LANTIS...Read More

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Company:Philips Medical Systems (Cleveland) Inc. Date of Enforcement Report 6/1/2011 Class ll: PRODUCT 1) Brilliance iCT, Computed Tomography X-Ray System, including the Brilliance iCT SP system, Model Numbers: 728311 and 728306. The affected systems are equipped with the following software version: 3.2.0.19010. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray...Read More

Company:Bio-Rad Laboratories Date of Enforcement Report 6/1/2011 Class ll: PRODUCT Software CD is labeled in part: “BLOOD VIRUS DIVISION***BIO-RAD EVOLIS System APF Version 4.4 Software Version 2.00 2009/05***” The EVOLIS Assay Protocol Files (APF) Software contains assay-specific instructions necessary for the EVOLIS Microplate processing system to process enzyme immunoassays on the EVOLIS instrument, perform data...Read More