When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.
Reason for recall: When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed. Distribution: Worldwide distribution: US (nationwide) and OUS countries of: Algeria, Armenia, Australia, Austria, Bangladesh, Bahrain, Bolivia, Plurinational state of, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Cyprus, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Neth Quantity: 10140 units Lot/code info: Serial Numbers: 24224, 24225, 130135, 220977, 1002250, 1007181, 1007187, 1009159, 1009160, 1009161, 1009162, 1009163, 1009186, 1009187, 1009188, 1009189, 1009190, 1009230, 1009231, 1009232, 1009233, 1009234, 1009235, 1009236, 1009237, 1009238, 1009239, 1010143, 1010144, 1010145, 1010146, 1010147, 1010148, 1010149, 1010150, 1010151, 1010152, 1010167, 1010170, 1010173, 1010174, 1010175, 1010176, 1011339, 1011340, 1011341, 1011342, 1011343, 1011344, 1011345, 1011346, 1011347, 1011348, 1011349, 1011350, 1011351, 1011352, 1011353, 1011354, 1011355, 1011356, 1011357, 1011358, 1011452, 1011453, 1011454, 1011455, 1011456, 1012169, 1012170, 1012171, 1012172, 1012173, 1012174, 1012175, 1012176, 1012177, 1012178, 1012179, 1012180, 1012181, 1012182, 1012183, 1102229, 1102230, 1102231, 1102232, 1102330, 1102331, 1102332, 1102413, 1102414, 1103190, 1103191, 1103226, 1103249, 1103250, 1103251, 1103252, 1103362, 1103388, 1103389, 1103390, 1103391, 1103392, 1104182, 1104183, 1104184, 1104185, 1104186, 1104187, 1104188, 1104189, 1104190, 1104191, 1104279, 1104280, 1104291, 1104292, 1104293, 1104320, 1104321, 1104322, 1104323, 1104324, 1105182, 1105209, 1105210, 1105211, 1105212, 1105213, 1105214, 1105215, 1105216, 1105217, 1105218, 1105296, 1105297, 1105298, 1105299, 1105300, 1105301, 1106124, 1106125, 1106127, 1106128, 1106129, 1106221, 1106244, 1106245, 1106246, 1106247, 1107142, 1107143, 1107144, 1107145, 1107146, 1107343, 1107344, 1107345, 1107346, 1108164, 1108165, 1108169, 1108171, 11081
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.