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U.S. Department of Health and Human Services

Class 2 Device Recall MAC 800 RESTING ECG ANALYSIS SYSTEM

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 Class 2 Recall
MAC 800 RESTING ECG ANALYSIS SYSTEM
see related information
Date Posted January 21, 2010
Recall Status1 Terminated on August 06, 2013
Recall Number Z-0645-2010
Recall Event ID 53164
Premarket Notification
510(K) Number
K090212 
Product Classification Electrocardiograph - Product Code DPS
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
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DPS and Original Applicant = GE MEDICAL SYST. INFORMATION TECHNOLOGIES
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