Company:GE Medical Systems
Date of Enforcement Report 2/3/2010
Class:ll
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. Recall # Recall # Z-0645-2010
REASON
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.
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, letter dated December 10, 2009.
Manufacturer: GE Medical Systems China Co., Ltd., Wuxi, China. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
567 units
DISTRIBUTION
Nationwide and Internationally
REASON
Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your “HIS” or “CIS”) and certain Picis applications, if that interface is not configured properly.
RECALLING FIRM/MANUFACTURER
Picis Inc., Wakefield, MA, by letter on April 8th 2009. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
325 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom
