Recall Z-1388-2016 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc. dba ArjoHuntleigh
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.
| Date | Dec 21, 2015 |
| Status | Terminated |
| Reason | Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose. |
| 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 |
| 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, Aust |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.