Recall Z-1388-2016— Arjo, Inc. dba ArjoHuntleigh
Class II · Terminated
Class II FDA medical device recall by Arjo, Inc. dba ArjoHuntleigh, initiated 2015-12-21, terminated 2018-06-25. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose..
- Recalling firm
- Arjo, Inc. dba ArjoHuntleigh
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-12-21
- Terminated
- 2018-06-25
- Firm location
- Addison, IL, United States
Product 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.
Reason for recall
Reports of the bolts connecting the stretcher to the hydraulic piston and the stretcher tilting mechanism becoming loose.
Data sourced from openFDA. This site is unofficial and independent of the FDA.