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 Class 2 Recall
MAC 800 RESTING ECG ANALYSIS SYSTEM		see related information
Date Posted January 21, 2010
Recall Number Z-0645-2010
Product GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment to record EGG signals from surface electrodes. The basic system shall provide 2 modes of operation: (I) Resting EGG mode and (2) Arrhythmia mode. The basic systems shall print 3, 6-leads of EGG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis.
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Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Reason for
Recall		 GE Healthcare has become aware of an issue with MAC800 laser printouts. When more than one ECG report in the file manager is batch printed in laser print, the potential exists for an incorrect patient identification or name to be displayed on the print out. Misidentification of patient data potentially contributing to delayed or incorrect treatment is then possible.
Action Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated December 10, 2009. The letter was addressed to Healthcare Administrator/Risk Manager, Chief of Nursing and Director of Biomedical Engineering. The letter described the Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. GE Healthcare will provide a software upgrade to resolve the issue. A GE Healthcare representative will contact customers to schedule implementation of the correction when it is available for installation at the customer facility. Direct questions to the GE Healthcare Technologies Support Center at 1-800-558-7044, enter Option 2 and ask for Technical Support or your local GE Field Service Representative.
Quantity in Commerce 567
Distribution Worldwide Distribution -- United States (CA, CO, CT, FL, IL,MD, NY, NC, OH, TN, TX, WA and WI), UNITED KINGDOM, UNITED ARAB EMIRATES, THAILAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVAKIA, SINGAPORE, ROMANIA, QATAR, PORTUGAL NETHERLANDS, LITHUANIA, KOREA, JAPAN, ITALY, ISRAEL, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, CZECH REPUBLIC, CROATIA, CHINA, BAHRAIN, AUSTRIA and AUSTRALIA.
 
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