Affected devices may be contained in the following serial number ranges. Model 1180: INITIAL RECALL serial numbers 100001 thru 100055. EXPANDED RECALL serial numbers 100117, 100140. Model 1181: INITIAL RECALL serial numbers 300001 thru 300050. EXPANDED RECALL serial number 300069 Model 1280: INITIAL RECALL serial numbers 500003 thru 500525. EXPANDED RECALL serial numbers 500034 thru 501339.
worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cyprus, Czechoslovakia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, Guyana, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Polynesia, Portugal, Reunion, Russia, Saudi Arabia, Singapore,Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan ROC, Turkey, United Kingdom, Uruguay and Venezuela. EXPANDED RECALL additional countries include: China, Croatia, Korea. Lithuania, Madagascar, Maldives, Malta, Monaco, Nepal and Thailand.
Descripción del producto
PULSAR MAX II (model nos. 1180, 1181 and 1280) pacemaker. Sterilized with gaseous ethylene oxide. Guidant . PULSAR MAX II pacemakers are multiprogrammable pacemakers from Guidant. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. Two sensors are available; these adapt the pacing rate to the patient's changing metabolic demand.