Class 2 Device Recall Arjo Maxi 500 Patient Lift with Manual 4Point DPS and Scale

• Date Initiated by Firm: October 30, 2008
• Date Posted: December 18, 2008
• Recall Status: Terminated on August 19, 2010
• Recall Number: Z-0413-2009
• Recall Event ID: 50098
• Product Classification: Non-ac-powered patient lift - Product Code FSA
• Product: Arjo Maxi 500 Patient Lift with Manual 4-Point DPS (Dynamic Positioning System) and Scale. A Non-AC-Powered Patient Lift. BHM Medical Inc., Magog, QC, Canada. Model KM560181 and Model KM560081 - Maxi 500 with 4-Point Spreader Bar, if it was equipped with the optional scale kit 700.19251.
• Code Information: Model KM560181, serial numbers: KM5610035, KM5610036, KM5610037, KM5610038, KM5610039, KM5610040, KM5610041, KM5610042, KM5610043, KM5610044, KM5610045, KM5610046, KM5610047, KM5610048, KM5610049, KM5610050, KM5610051, KM5610052, KM5610053, KM5610054, KM5610055, KM5610056, KM5610057, KM5610058, KM5610059, KM5610060, KM5610061, KM5610062, KM5610063, KM5610064, KM5610065, KM5610066, KM5610096, KM5610097, KM5610098, KM5610099, KM5610100, KM5610101, KM5610102, KM5610103, KM5610104, KM5610105, KM5610106, KM5610107, KM5610108, KM5610109, KM5610110, KM5610111, KM5610112, KM5610113, KM5610116, KM5610117, KM5610118, KM5610119, KM5610120, KM5610121, KM5610122, KM5610123, KM5610124, KM5610125, KM5610126, KM5610127, KM5610128, KM5610129, KM5610130, KM5610131, KM5610132, KM5610133, KM5610152, KM5610153, KM5610154, KM5610155, KM5610156, KM5610157, KM5610158, KM5610159, KM5610160, KM5610161, KM5610162, KM5610163, KM5610164, KM5610165, KM5610166, KM5610167, KM5610168, KM5610169, KM5610170, KM5610171, KM5610173, KM5610176, KM5610177, KM5610178, KM5610179, KM5610180, KM5610181, KM5610182, KM5610187, KM5610235, KM5610236, KM5610237, KM5610238, KM5610239, KM5610240, KM5610241, KM5610242, KM5610243, KM5610244, KM5610245, KM5610246, KM5610247, KM5610249, KM5610250, KM5610251, KM5610253, KM5610254, KM5610257, KM5610260, KM5610261, KM5610262, KM5610263, KM5610264, KM5610265, KM5610266, KM5610267, KM5610268, KM5610269, KM5610270, KM5610271, KM5610272, KM5610273, KM5610274, KM5610275, KM5610276, KM5610278, KM5610280, KM5610281, KM5610282, KM5610284, KM5610285, KM5610286, KM5610288, KM5610289, KM5610290, KM5610291, KM5610292, KM5610293, KM5610294, KM5610295, KM5610296, KM5610297, KM5610298, KM5610299, KM5610300, KM5610301, KM5610302, KM5610303, KM5610304, KM5610305, KM5610306, KM5610307, KM5610308, KM5610309, KM5610310, KM5610311, KM5610312, KM5610313, KM5610314, KM5610315, KM5610316, KM5610317, KM5610318, KM5610319, KM5610320, KM5610321, KM5610322, KM5610323, KM5610324, KM5610325, KM5610326, KM5610327, KM5610328, KM5610329, KM5610330, KM5610331, KM5610332, KM5610333, KM5610334, KM5610335, KM5610336, KM5610337, KM5610338, KM5610339, KM5610340, KM5610341, KM5610342, KM5610343, KM5610406, KM5610407, KM5610408, KM5610409, KM5610410, KM5610411, KM5610412, KM5610413, KM5610414, KM5610415, KM5610416, KM5610417, KM5610418, KM5610419, KM5610420, KM5610421, KM5610422, KM5610423, KM5610424, KM5610425, KM5610426, KM5610427, KM5610428, KM5610429, KM5610430, KM5610431, KM5610432, KM5610433, KM5610434, KM5610435, KM5610436, KM5610437, KM5610438, KM5610439, KM5610440, KM5610441, KM5610596, KM5610700, KM5610701, KM5610702, KM5610703, KM5610704, KM5610722, KM5610723, KM5610724, KM5610725, KM5610726, KM5610735, KM5610736, KM5610748, KM5610749, KM5610750, KM5610751, KM5610752, KM5610753, KM5610754, KM5610755, KM5610756, KM5610757, KM5610758, KM5610784, KM5610785, KM5610786, KM5610787, KM5610788, KM5610805, KM5610806, KM5610808, KM5610814, KM5610815, KM5610816, KM5610817, KM5610818, KM5610824, KM5610825, KM5610826, KM5610827, KM5610828, KM5610830, KM5610831, KM5610832, KM5610833, KM5610839, KM5610840, KM5610841, KM5610842, KM5610843, KM5610849, KM5610850, KM5610851, KM5610852, KM5610853, KM5610854, KM5610855, KM5610856, KM5610857, KM5610858, KM5610878, KM5610879, KM5610880, KM5610881, KM5610888, KM5610889, KM5610890, KM5610891, KM5610892, KM5610913, KM5610914, KM5610915, KM5610916, KM5610950, KM5610951, KM5610952, KM5610953, KM5610954, KM5610978, KM5610980, KM5610981, KM5610982, KM5610983, KM5610984, KM5610985, KM5610986, KM5610987, KM5610988, KM5610989, KM5610990, KM5610991, KM5610992, KM5610998, KM5610999, KM5611001, KM5611002, KM5611093, KM5611096, KM5611097, KM5611098, KM5611099, KM5611101, KM5611121, KM5611123, KM5611124, KM5611125, KM5611137, KM5611138, KM5611139, KM5611187, KM5611188, KM5611190, KM5611233, KM5611235, KM5611237, KM5611293, KM5611294, KM5611295, KM5611296, KM5611307, KM5611324, KM5611327, KM5611329, KM5611330, KM5611331, KM5611395, KM5611396, KM5611402, KM56510015, KM56510016, KM56510017, KM56510018, KM56510019, KM56510020, KM56510021, KM56510022, KM56510023 and KM56510024; Scale model 700.19251, serial numbers: SO#5178400, SO#5143612, SO#5204405, SO#5186264, SO#5137047, SO#5150226, SO#5156912, SO#5162379, SO#5165403 and SO#5142409.
• Recalling Firm/ Manufacturer: Arjo, Inc.; 50 Gary Ave; Roselle IL 60172-1605
• For Additional Information Contact: Ms. Traci Giovenco; 800-323-1245 Ext. 6125
• Manufacturer Reason for Recall: If the spring pin is not properly reinstalled after maintenance, the pivot bolt could unscrew by itself within a limited period of time, resulting in a hanger bar detachment.
• FDA Determined Cause: Employee error
• Action: Arjo, Inc. sent an Urgent Device Recall Customer Notification letter dated 10/29/08 to all affected end users to the attention of the Administrator/Risk Manager via UPS 2nd day on the 10/30/08. The letters informed the accounts of the potential for the hanger bar to detach from the scale if the spring pin is not replaced into the pivot bolt after performing maintenance on the lift. The accounts were advised to review the enclosed Urgent Field Safety Notice, note the affected model and serial numbers, and inspect their lifts for the presence of the spring pin in the pivot bolt. If the user finds that the spring pin is missing, they are instructed to immediately stop using the lift and contact their Arjo representative. The accounts were also instructed to remove previous versions of the Operating and Product Care instructions, and replace them with the current version 001.20815.EN Rev3 dated October 2008 provided with the letter, ensuring that the proper personnel are made aware of the changes outlined in the Field Safety Notice. Direct questions to the Arjo, Inc. Quality Department at 800-323-1245, ext. 6118. The accounts were also instructed to complete and fax (888-594-2756) to Arjo, Inc. the enclosed Customer Response Form, providing the facility name and address, contact name and phone number, the numbers of affected units, and acknowledgment of receipt and understanding of the Field Safety Notice.
• Quantity in Commerce: 371 lifts, 10 scale kits
• Distribution: Nationwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.