Class 2 Device Recall Arjo Ambulift Classic

• Date Initiated by Firm: May 05, 2008
• Date Posted: August 28, 2008
• Recall Status: Terminated on February 03, 2010
• Recall Number: Z-1651-2008
• Recall Event ID: 47885
• Product Classification: Lift, Patient, Non-AC powered - Product Code FSA
• Product: Ambulift Classic, battery powered patient lift. The Ambulift is used to move and lift patients from their beds, transport them to the bathroom, and lift them in and out of the bath. Model KDB1890-04US - Ambulift Classic with chair and leg rest. Model KDB1895-04US - Ambulift Classic with chair, leg rest and scale.
• Code Information: Models AKDB1890-04US and AKDB1895-04US, all serial numbers
• Recalling Firm/ Manufacturer: Arjo, Inc.; 50 Gary Ave Ste A; Roselle IL 60172-1684
• For Additional Information Contact: Ms. Traci Giovenco; 630-307-2756
• Manufacturer Reason for Recall: The armrests of the lift chair may push up, allowing the patient to slip down and out of the seat. The resultant fall could result in serious or fatal patient injuries.
• FDA Determined Cause: Device Design
• Action: Arjo sent Customer Field Correction Notification letters dated 5/2/08 on the Arjo letterhead to the end user accounts who received the affected Ambulift Patient Lifts, to the attention of the Administrator/Risk Manager, via UPS 2nd day delivery on 5/5/08. The letters informed the consignees of the incident with the patient slipping from the seat of the lift and sustaining fatal injuries and advised them to always ensure that a clinical assessment to verify that the resident has sufficient upper body strength to maintain a steady position on the chair, and that the resident has sufficient mental capacity to adhere to the caregiver's instructions, is carried out by a qualified nurse or therapist before lifting residents with the Ambulift. To further enhance safety, a seat belt is being made available, which must be fitted to the chair, enabling it to be used when required by clinical assessment. Instructions on how to apply, use, and maintain the seat belt will be provided with the belts. The belts will be provided at no cost. The accounts were requested to review, complete and return the enclosed customer response form, indicating the number seat belts needed. Any questions were directed to Arjo's Quality Department at 1-800-323-1245, ext. 6140 or 6165.
• Quantity in Commerce: 3 lifts
• Distribution: Worldwide Distribution-USA includes the states of AL, AZ, DE, FL, KY, MO, NY, OK, and VA
• 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.