The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and...
FDA Recall #Z-1388-2016 — Class II — December 21, 2015
Product Description
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.
Reason for Recall
Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.
Recalling Firm
Arjo, Inc. dba ArjoHuntleigh — Addison, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated