Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed.

Recall details

Manufacturer

Arjo, Inc. dba ArjoHuntleigh

Distributor

Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Netherlands, New Zealand, Northern Ireland, Norway, Poland, Portugal, Quatar, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland and Turkey

Lot

Models HEP0001-US, serial numbers SPSN0808U285, PN1010U507, PN1102U092, PN1102U110, SPSN0905U022, SPSN0907U048, SPSN0909U091, SPSN0605U388, SPSN0810U506, PN1102U093, PN1102U101, PN1102U112, PN1104U199, PN1104U201, PN1104U203, PN1104U214, PN1104U215, PN1104U216, PN1104U217, PN1104U220, PN1104U224, PN1104U225, PN1106U365, SPSN0804U387, SPSN0605U421, SPSN0605U423, SPSN0605U425, SPSN0605U431, SPSN0605U432, SPSN0605U440, SPSN0605U199, SPSN0605U365, SPSN0901U033, SPSN0605U206, SPSN0605U214, SPSN0605U217, SPSN0605U220, SPSN0801U071, SPSN0801U072, SPSN0707U484, SPSN0709U689, SPSN0709U692, SPSN0709U693, SPSN0710U842, P0129686, P0123033, SPSN0808U284, P0120989, SPSN0703U140, P0116656, SPSN0605U241, SPSN0605U242, SPSN0605U243, SPSN0605U244, SPSN0605U245, SPSN0605U246, SPSN0605U247, SPSN0605U248, SPSN0605U249, SPSN0605U350, SPSN0605U351, SPSN0605U352, SPSN0605U353, SPSN0808U199, PN1009U430, PN1008U393, SPSN0904U419, SPSN0906U038, SPSN0605U138, SPSN0605U140, SPSN0605U145, SPSN0605U148, SPSN0605U153, SPSN0605U414, SPSN0605U416, SPSN0605U420, P0121743, SPNS0706U431, SPNS0706U433, SPNS0706U443, SPNS0706U445, SPSN0605U412, SPSN0605U442, SPSN0605U447, SPSN0605U451, SPSN0605U461, SPSN0605U469, SPSN0605U473, SPSN0605U480, SPSN0704U296, SPSN0704U297, SPSN0704U300, SPSN0704U301, SPSN0709U767, SPSN 907U052, SPSN0705U398, PN1101U039, P0122276, SPSN0605U355, SPSN0605U356, SPSN0605U373, SPSN0605U375, PN1104U219, SPSN0605U362, SPSN0605U189, SPSN0605U233, SPSN0605U212, SPSN0605U237, SPSN0703U123, SPSN0703U129, SPSN0707U456, SPSN0707U466, SPSN0707U467, SPSN0707U468, SPSN0707U470, SPSN0707U475, SPSN0707U480, SPSN0707U483, SPSN0707U485, SPSN0710U878, SPSN0710U882, SPSN0904U415, SPSN0907U040, SPSN0907U060, SPSN0908U031, SPSN0605U378, SPSN0810U502, SPSN0801U073, SPSN0605U226, PN1010U517, SPSN0904U437, SPSN0904U442, SPSN0904U447, SPSN0904U453, SPSN0906U004, SPSN0906U007, SPSN0906U009, SPSN0906U012, SPSN0906U013, SPSN0906U014, SPSN0906U016, SPSN0803U350, PN1101U049, PN1101U054, PN1101U056, PN1106U379, SPSN0605U407, SPSN0605U410, SPSN0605U415, SPSN0901U029, SPSN0901U030, SPSN0901U036, SPSN0901U037, SPSN0901U041, SPSNO605U178, SPSNO605U179, SPSN0703U127, P0130066, SPSN0605U134, SPSN0605U149, SPSN0605U150, SPSN0902U218, SPSN0904U423, SPSN0705U395, SPSN0901U107, SPSN0901U023, SPSN0901U039, PN1104U242, SPSN0901U050, SPSN0808U164, SPSN0907U029, SPSN0703U198, SPSNO605U167, SPSN0605U411, PN1104U247, PN1105U293, SPSN0605U210, SPSN0807U145, SPSN0808U156, SPSN0808U163, SPSN0808U165, SPSN0808U166, PN1006U301, SPSN0907U038, SPSN0605U471, SPSN0605U418, SPSN0605U208, PN1105U306, SPSN0811U602, SPSN0909U088, SPSN0702U046, SPSN0702U047, SPSN0702U048, SPSN0702U052, SPSN0702U054, SPSN0702U055, SPSN0804U390, SPSN0901U040, P0130065, SPSN0705U393, SPSN0707U473, SPSN0710U849, PN1104U252, P0120986, SPSN0810U497, PN1010U510, P0116659, SPSN0904U379, SPSN0904U380, SPSN0904U392, SPSN0904U394, SPSN0904U395, PN1010U508, SPSN0810U408, SPSN0810U419, SPSN0605U177, SPSN0808U283, SPSNO605U166, SPSN0803U343, SPNS0706U437, SPNS0706U447, SPSN0605U390, PN1008U381, SPSN0605U370, SPSN0703U125, SPSN0805U036, SPSN0805U038, SPSNO605U168, SPSNO605U181, SPSNO605U184, SPSN0605U234, SPSN0902U208, SPSN0605U401, SPSN0707U478, SPSN0605U221, PN1105U312, PN1008U382, PN1106U361, SPSN0710U844, SPSN0809U371, SPSN0808U280, SPSN0709U762, SPSN0801U064, SPSN0803U346, SPSN0904U393, SPSN0605U400, SPSN0806U075, SPSN0806U076, SPSN0806U077, SPSN0806U079, SPSN0707U481, SPSN0905U019, P0109559, P0109642, SPSN0605U474, SPSN0709U694, PO106458, SPSN0709U763, SPSN0901U112, SPSN0605U384, SPSN0810U423, SPSN0605U205, SPSN0804U377, SPSN0605U194, SPSN0904U388, SPSN0709U688, SPSN0710U883, SPSN0710U896, SPSN0810U512, SPSN0904U429, SPSN0605U462, SPSN0605U385, SPSN0605U387, SPSN0605U231, SPSN0605U235, PN1009U439, SPSN0801U132, SPSN0801U135, SPSN0801U136, SPSN0904U439, SPSN0904U443, PN1101U038, PN1102U079, PN1102U094, PN1102U105, PN1104U196, SPSN0805U037, SPSN0707U461, SPSN0605U419, PN1105U305, SPS

Risk classification

Class II

Area (FDA)

device

Country

United States