{"id":366,"date":"2013-05-19T21:22:55","date_gmt":"2013-05-19T21:22:55","guid":{"rendered":"https:\/\/www.drug-injury-lawyer.com\/?p=366"},"modified":"2013-06-13T21:37:01","modified_gmt":"2013-06-13T21:37:01","slug":"class-i-recall-issued-for-ge-healthcare-incubators","status":"publish","type":"post","link":"https:\/\/www.drug-injury-lawyer.com\/2013\/05\/19\/class-i-recall-issued-for-ge-healthcare-incubators\/","title":{"rendered":"Class I Recall Issued for GE Healthcare Incubators"},"content":{"rendered":"<p><a href=\"http:\/\/www.flickr.com\/photos\/60134535@N00\/8593907484\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright\" alt=\"\" src=\"http:\/\/static.flickr.com\/8101\/8593907484_6cea26cb5a.jpg\" width=\"300\" height=\"225\" \/><\/a>GE\u00a0Healthcare\u00a0designed two products &#8211;\u00a0the Giraffe OmniBed and the Giraffe Incubator\u00a0\u2013 to provide thermal and developmental care to newborn babies.\u00a0 These products are used to maintain the body temperature and, in some models, the oxygen level of newborn babies.<\/p>\n<p>The Giraffe OmniBed can function in either the closed mode as an incubator or in the open mode as a warmer, and can transition from one mode to another depending upon the user\u2019s demand.\u00a0 The Giraffe Incubator provides heat through a closed, temperature-controlled environment that maintains the\u00a0body temperature of a newborn infant, with some models containing a\u00a0 controlled oxygen delivery system that\u00a0can be used to provide oxygen to newborn babies, as well.<\/p>\n<p>The Food and Drug Administration (FDA) issued a <a href=\"http:\/\/www.fda.gov\/MedicalDevices\/Safety\/ListofRecalls\/ucm349245.htm\" target=\"_blank\"><span style=\"color: #0066cc;\">Class I Recall<\/span><\/a> in April for certain models of GE\u2019s Giraffe OmniBed and Giraffe Incubators manufactured and distributed between August 2012 to December 2012.\u00a0 Those models being recalled may, when recovering from a power failure,\u00a0delete stored information and then enter new erroneous information in its place.\u00a0 Should this occur, the heater or oxygen delivery option is turned off, the new set point will be \u201c0\u201d, and alarms may fail to alert healthcare personnel that either the heater or oxygen delivery options are \u201coff\u201d or that\u00a0 set points are lower than intended.<\/p>\n<p><strong><a href=\"http:\/\/news.google.com\/news\/url?sa=t&amp;fd=R&amp;usg=AFQjCNHSVbVloRQuppVkhdYVrYVqtrqPSg&amp;url=http:\/\/www.dailynewsegypt.com\/2013\/05\/26\/egypts-incubator-shortage-a-medical-tragedy\/\">Egypt&#8217;s incubator shortage: A medical tragedy<\/a><\/strong><\/p>\n<p>Any newborn baby using these devices during a power outage may suffer serious adverse health consequences, including death, due to this malfunction.\u00a0 Adverse health consequences include inaccurate body temperature, which can result in either hypothermia (dangerously low body temperature) or hyperthermia (dangerously high body temperature), and inaccurate oxygen regulation, which can result in hypoxia (low blood oxygen) or hyperoxia (high blood oxygen).<\/p>\n<p>GE Healthcare will correct all affected devices at no cost to customers and urges all healthcare professionals to report any adverse reactions related to use of the Giraffe OmniBed and\/or Giraffe Incubator to the FDA\u2019s MedWatch Safety Information and Adverse Reporting Program online or by calling their toll free number: <a href=\"tel:1-800-332-1088\" target=\"_blank\">1-800-332-1088<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>GE\u00a0Healthcare\u00a0designed two products &#8211;\u00a0the Giraffe OmniBed and the Giraffe Incubator\u00a0\u2013 to provide thermal and developmental care to newborn babies.\u00a0 These products are used to maintain the body temperature and, in some models, the oxygen level of newborn babies. The Giraffe &hellip; <a href=\"https:\/\/www.drug-injury-lawyer.com\/2013\/05\/19\/class-i-recall-issued-for-ge-healthcare-incubators\/\">Read More<\/a><\/p>\n","protected":false},"author":12,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-366","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.drug-injury-lawyer.com\/wp-json\/wp\/v2\/posts\/366","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.drug-injury-lawyer.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.drug-injury-lawyer.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.drug-injury-lawyer.com\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/www.drug-injury-lawyer.com\/wp-json\/wp\/v2\/comments?post=366"}],"version-history":[{"count":1,"href":"https:\/\/www.drug-injury-lawyer.com\/wp-json\/wp\/v2\/posts\/366\/revisions"}],"predecessor-version":[{"id":367,"href":"https:\/\/www.drug-injury-lawyer.com\/wp-json\/wp\/v2\/posts\/366\/revisions\/367"}],"wp:attachment":[{"href":"https:\/\/www.drug-injury-lawyer.com\/wp-json\/wp\/v2\/media?parent=366"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.drug-injury-lawyer.com\/wp-json\/wp\/v2\/categories?post=366"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.drug-injury-lawyer.com\/wp-json\/wp\/v2\/tags?post=366"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}