Recall Z-1046-04 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc.
Alenti Lift Hygiene Chair; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers CDB8003-01-US and CDB8053-01-US (with scale)
| Date | Jul 20, 2004 (initiated Jun 8, 2004) |
| Status | Terminated |
| Reason | There has been an increased number of tipping incidents and subsequent patient injuries. |
| Root cause | Other |
| Action | Safety Advice Notice letters dated 6/8/04 were sent by certified mail to the end users, informing them of the possibility of tipping if the Alenti catches on other equipment; if the resident is not positioned correctly on the chair; if the Alenti is used with an inappropriate resident; if the resident is left unattended, particularly when the Alenti is in an elevated position; and if the safety belt is not used as a positioning belt. The end users were provided with a laminated hang tag to place on the lift with the listed safety aspects and warnings, a copy of the revised Alenti Operating an |
| Quantity | 1,035 units |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.