Recall Z-0409-2013 ยท IOQ Bed, Flotation Therapy, Powered
KCI USA, Inc.
RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
| Date | Nov 20, 2012 (initiated Jun 27, 2012) |
| Status | Terminated |
| Reason | The firm is initiating a voluntary medical device correction for the RotoRest Delta Therapy System head pack. KCI has received complaints alleging patients experiencing skin breakdown on the head and face due to the positioning of the head pack. In a few instances, the patient received injuries ranging from Stage III to Stage IV pressure ulcers. |
| Root cause | Component design/selection |
| Action | KCI sent an Urgent - Voluntary Medical Device Correction letter dated June 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that KCI would contact them soon to coorinate a shipment of a replacement of the affected product. For any questions customers were instructed to call 1-800-275-4524, Selection Option 3 followed by Option 2. For questions regarding this recall call 1-800-275-4524. |
| Quantity | 282 units |
| Distribution | Nationwide Distribution including AL, CA, CO, OK and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.