Recall Z-2182-2011 ยท IKZ Bed, Patient Rotation, Powered
KCI USA, Inc.
KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.
| Date | May 10, 2011 (initiated Feb 18, 2011) |
| Status | Terminated |
| Reason | Buckles used to secure patient to surface during proning therapy can come open if not properly engaged by user. |
| Root cause | Device Design |
| Action | Firm sent a letter with the "Warning: Improper Insertion of the RotoProne Therapy System Buckle Can Lead To Unintentional Bed Exit" to all consignees on 2/23/2011. The letter identified the affected product and the reason for the recall. Customers were instructed to read the attached product warning regarding the proper method to attach the RotoProne buckles and to post it with the device to ensure continued proper use of the buckles. If customers had questions regarding the proper use of the buckles, they were to contact KCI Customer Technical Service at 1-800-275-4524. |
| Quantity | 229 units |
| Distribution | Worldwide Distribution - USA and Kuwait. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.