Class 2 Device Recall Arjo Flat Dynamic Positioning System (DPS)

• Date Initiated by Firm: October 06, 2020
• Create Date: February 09, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1100-2021
• Recall Event ID: 86578
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to ceiling lift or passive floor lift.
• Code Information: LBA1030-xx, LCA80563-xx, LCA81695-xx, KTX01440.xx, LBX05420-xx, LBX1033-xx, KTS0010
• Recalling Firm/ Manufacturer: Arjohuntleigh Magog, Inc.; 2001 Tanguay St; Magog Canada
• Manufacturer Reason for Recall: Risk of Sling Clip breakage while in use with obsolete Flat Dynamic Positioning System (DPS)
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 10/06/2020, the firm sent a letter to its consignees with the following instructions. Arjo has become aware that there is a likelihood that a sling clip may break (Image 2) when used with the models of spreader bars referenced above that are out of their lifespan (see note 1 below). The continued use of the obsoleted DPS can lead to complete clip breakage and subsequently to its detachment from the DPS attachment point. As a consequence, the resident may fall off and potentially sustain serious injuries as a consequence. Arjo is taking this matter very seriously and recommends replacement of the obsoleted DPS on ceiling lift or floor lift systems. Note 1: The probability of the event may increase if the DPS is used with a Clip Sling that has exceeded its expected lifespan of 2 years or more than 1.5 years for Passive Clip Slings models MAA2080M, MAA2050M, MAA2040M, MAA2070M and MLAAS2000. Next Steps 1. Verify whether you possess DPS within the range of this Notice and ensure that all caregivers and users of Arjo ceiling lift or floor lifts are made aware of this Field Safety Notice (FSN). 2. Complete and sign the enclosed Customer Response Form and return this document to your local Arjo office. Contact your local Arjo office to take the appropriate decision regarding your obsolete device(s) and select the best solution for your needs. NOTE: Until you find with our Arjo representative the most appropriate solution for your patient transfer needs, the device may stay in use strictly if those two conditions are fulfilled; A. Before each patient transfer, ensure to follow the recommendation of the Sling Instruction for Use and check all parts of the sling are free of any damage B. Ensure the sling used is within its intended lifetime (2 years or 1.5 years for Passive Clip Slings models MAA2080M, MAA2050M, MAA2040M, MAA2070M and MLAAS2000). In addition, if the label of the sling is faded, unreadable or damaged, ensure sling disposal as recomme
• Quantity in Commerce: 3390 units
• Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, GA, IA, ID, IL, IN, KS, KY, LA, MI, MN, MO, MS, MT, NC, NE, NH, NY, OH, OK, SC, SD, TN, TX, UT, VA, WI and the countries of Australia, Belgium, Canada, Czech Republic, France, Italy and Poland.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.