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.
Recall
- Recall Number
- Z-1388-2016
- Event Number
- 73054
- Firm
- Arjo, Inc. dba ArjoHuntleigh
- FEI Number
- 1419652
- Product Code
- FSA
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- December 21, 2015
- Terminated
- June 25, 2018
- Address
- 2349 W Lake St, Addison, IL, 60101-6183
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.
Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.
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
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.
1,596 units