Medical device recalls Moderate risk

Arjo, Inc. dba ArjoHuntleigh recalls The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents…

Recall date
December 21, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1388-2016
FDA classification
Class II
Brand / firm
Arjo, Inc. dba ArjoHuntleigh
Sold / distributed
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, Austr…

Why it was recalled

Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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