Z-1388-2016Class II

The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of...

Name: Z-1388-2016 The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of...
Creator: Arjo, Inc. dba ArjoHuntleigh
Published: 2015-12-21
License: https://open.fda.gov/license/

Arjo, Inc. / initiated 2015-12-21 / Terminated

FDA source

Arjo, Inc. dba ArjoHuntleigh began a recall of The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and bathing of residents in care environments such as... on 2015-12-21. FDA classified it as Class II and gives the reason as "Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1388-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-21
Posted: 2016-04-14
Terminated: 2018-06-25
Recalling firm: Arjo, Inc.
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.
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1388-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1388-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-13

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)