ClearanceBrief
Recall Z-0645-2010 ยท DPS Electrocardiograph

GE Medical Systems, LLC

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

DateJan 21, 2010 (initiated Dec 10, 2009)
StatusTerminated
ReasonGE 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.
Root causeSoftware design
ActionConsignees 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 quest
Quantity567
DistributionWorldwide 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, G
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K090212MAC 800 RESTING ECG ANALYSIS SYSTEM
Ge Medical Syst. Information Technologies, Feb 19, 2009