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Recall Observatory FDA recall evidence

Device 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.

Z-1388-2016

December 21, 2015

Class II

Product summary

Firm
Arjo, Inc. dba ArjoHuntleigh
Event
Event 73054
Status
Terminated
Classification
Class II
Quantity
1,596 units
Official record key
device-enforcement:Z-1388-2016

Official wording

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

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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