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Physio-Control, Inc. recalls LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (include
Recalled June 22, 2016 · FDA recall Z-1993-2016 · Physio-Control
Hazard
The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtC02 value. This affects all LIFEPAK 15 with an EtC02 feature installed and configured to the kPa or % setting. · FDA Class II
Units
44798 units total (23189 units in US; 21609 units international)
Sold at
Worldwide Distribution - US (nationwide) including Guam and Puerto Rico and Internationally to ¿land Islands, Algeria, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Barbados, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Cambodia, Canada, Cayman Islands, Chile, China, Costa Rica, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Eritrea, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guinea, Guyana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, the former Yugoslav Republic of, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Morocco, Mozambique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Pakistan, Panama, Papua New Guinea, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Province of China, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Yemen.
Description
The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtC02 value. This affects all LIFEPAK 15 with an EtC02 feature installed and configured to the kPa or % setting.
Product
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
Manufacturer(s)
Physio-Control, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →