Recall Z-2230-2009 ยท FSA Lift, Patient, Non-Ac-Powered
ArjoHuntleigh
Maxi Move Scoop Stretcher; Note: The stretcher is an accessory to the Maxi Move Patient Lift; Made by Arjo Hospital Equipment AB, Eslov, Sweden; product number KRA2210-20.
| Date | Sep 22, 2009 (initiated Aug 18, 2009) |
| Status | Terminated |
| Reason | A Scoop Stretcher is made up of two frames that are held together with two locking devices, one on each end. Each locking device contains a safety latch. The safety latch could unintentionally release when the side frames are pulled for positioning. |
| Root cause | Manufacturing material removal |
| Action | ArjoHuntleigh sent their customers a cover letter and the Field Safety Notification, informing them of the potential problem with the safety latches on the stretcher and a pending visit from an ArjoHuntleigh Service Technician to correct the problem. These letters were sent via UPS 2nd day delivery on 8/18/09. The customers were requested to test their stretchers upon receipt of the letter following the instructions for checking the safety latches on the stretcher: * Place the stretcher on its side on a non-scratch surface. * Try to pull the two sides apart with the safety latch engaged. * T |
| Quantity | 214 units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.