Class 2 Device Recall Quick Connect 272 KG Scale

• Date Initiated by Firm: February 12, 2018
• Create Date: August 07, 2018
• Recall Status: Terminated on August 20, 2020
• Recall Number: Z-2661-2018
• Recall Event ID: 80465
• Product Classification: Quick Connect Scale - Product Code FSA
• Product: Q-Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care facilities.
• Code Information: Product Code 700-19490: starting from serial number 300142013 up to serial number 300219867.
• Recalling Firm/ Manufacturer: Arjohuntleigh Magog; 2001 Rue Tanguay; Magog Canada Quebec
• For Additional Information Contact: Yvonne McMann (US ONLY); 210-278-7000
• Manufacturer Reason for Recall: The spreader bar can detach from the scale attachment under certain conditions.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Thefirm, ARJO, sent an "Urgent-A Field Safety Notice" and Customer Response Forms to affected customers by common carrier and signature required. All affected customers need to ensure that all caregivers and users of the affected devices a remade aware of the Field Safety Notice and all listed devices at their facility are available to be corrected during service technician visit. Affected customers need also to review the Field Safety Notice, acknowledge receipt and understanding of the Field Safety Notice and the required actions by completing, signing and returning the Customer Response Form to the local Arjo office. The Arjo Sales and Service office shall arrange Arjo service technician to visit the facilities to carry out the upgrade of the scales attachment on Maxi Sky 2 ceiling lifts. If you have any further questions or require assistance completing the Customer Response Form, please contact Arjo via email at ArjoCustomer.Response-US@Arjo.com
• Quantity in Commerce: 874 Units (both styles)
• Distribution: Worldwide distribution: US (nationwide) to states of: CO, FL, IA, IL, KY, MN, NY, PH, and WA; and countries of: Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Italy, Japan, Netherlands, Norway, Singapore, Swiss, Turkey, United Kingdom, and United Arab Emirates.
• 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.