Recall Z-0926-2014 ยท IKZ Bed, Patient Rotation, Powered
ArjoHuntleigh Inc.
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndro
| Date | Feb 4, 2014 (initiated Sep 11, 2013) |
| Status | Terminated |
| Reason | The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient |
| Root cause | Device Design |
| Action | ArjoHuntleigh Inc. sent a Technical Bulletin package to all affected service centers and an Urgent Field Safety Notice package to all affected customers. For rental units, a training plan was established for employees. For sold units, the notice contain a revised user manual and label explaining what to do if the lock pin becomes stuck in the "in" position. Customers that purchased the affected product were required to complete and return a Customer Response form to ArjoHuntleigh to confirm receipt and understanding of the field safety notice, and that the required actions were completed. |
| Quantity | 231 units |
| Distribution | US Nationwide and Middle East |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.