Recall Z-1949-2012 ยท FSA Lift, Patient, Non-Ac-Powered
Arjo, Inc. dba ArjoHuntleigh
Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B-3930 Hamont-Achel, Belgium; Models HEP0001-US and HEP1001-US. The Sara Plus is a standing and raising aid for short transfers e.g. raising from bed and transfer to wheelchair, or from wheelchair to toilet. Sara Plus is also suitable for walking training when the footboard and kneepad are removed.
| Date | Jul 6, 2012 (initiated Jun 29, 2012) |
| Status | Terminated |
| Reason | ArjoHuntleigh has received a limited number of customer reports concerning injuries related to an exposed metal support bracket when the proactive knee pad assembly is removed. |
| Root cause | Labeling False and Misleading |
| Action | ArjoHuntleigh sent an "URGENT FIELD CORRECTION RECALL" notice dated June 25, 2012, to all affected customers via UPS Ground on June 29, 2012. The notice informed the accounts of the potential for severe patient injury if the proactive knee pad support is removed from the lift without the removal of the knee pad support bracket. The accounts were reminded that the entire knee pad and support bracket assembly must be removed from the lift when required to do so for exercise. An additional warning statement with diagrams was included in the notice. The accounts were requested to disseminate the |
| Quantity | 2480 units in U.S., 2,651 units in the rest of the world |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, Bermuda, Canada, Cyprus, Czech Republic, Denmark, Dubai, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Kenya, Korea, Luxembourg, the Ne |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.