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U.S. Department of Health and Human Services

Class 2 Device Recall ArjoHuntleigh Inc.

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  Class 2 Device Recall ArjoHuntleigh Inc. see related information
Date Initiated by Firm December 21, 2015
Create Date April 14, 2016
Recall Status1 Terminated 3 on June 25, 2018
Recall Number Z-1388-2016
Recall Event ID 73054
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as senior/assisted living, group home, special care, nursing homes, hospitals and home care. The Concerto Basic Shower Trolley is intended for indoor use.
Code Information All Concerto & Basic Shower Trolleys manufactured by ArjoHuntleigh Polska Sp. z o.o, March 7, 2014 through April 20, 2015 with serial numbers from P0227559 - P0322393  
Recalling Firm/
Arjo, Inc. dba ArjoHuntleigh
2349 W Lake St
Addison IL 60101-6183
For Additional Information Contact Brenda Ammonette
Manufacturer Reason
for Recall
Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.
FDA Determined
Cause 2
Process change control
Action An Urgent Field Safety Notice and Customer Response form was mailed to affected customers describing the reason fro the recall and the actions to be taken. The instruction to customers is to review the Field Safety Notice and complete the Customer Response Form to acknowledge receipt and understanding of the Field Safety Notice and the required actions. These actions taken are as follows: 1. Ensure that all caregivers and users of the ArjoHuntleigh Concerto or Basic Shower Trolley are made aware of this Field Safety Notice (FSN) and all affected Concerto Shower Trolleys at your facility will be available for inspection by an ArjoHuntleigh Service Technician. 2. Ensure that a copy of this field safety notice (FSN) is placed in the Concerto/Basic Shower Trolley Instructions for Use manual for future reference and training. 3. Complete and sign the enclosed Customer Response Form and return this form to the ArjoHuntleigh Regulatory Department. Note: ArjoHuntleigh will contact the designated facility representative listed on the Customer Response Form to schedule service to inspect and upgrade your device, free of charge. ArjoHuntleigh advises customers to distribute the notice to those individuals who need to be aware within their organization or to any organization where the potentially affected devices have been transferred. Additionally the they should maintain awareness of the notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. The Notice includes a Note for the customer to inform FDA of adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. The letter states that if the cusstomer has additional questions or they require assistance completing the Customer Response Form, please contact ArjoHuntleigh at 1-800-323-1245, ext. 57985 or via email at AHNA-RA
Quantity in Commerce 1,596 units
Distribution US Consignees; 222 units distributed in the following states: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI and WV. ***Foreign Consignees; 1374 units distributed in the following countries: Australia, Austria, Belgium, Bosnia & Hercegovina, Brazil, CANADA, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Iceland, Ireland, Italy, Japan, Lithuania, Luxemburg, Netherlands, New Zealand, Nigeria, Norway, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan and UK.
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.