Recall Z-1980-2013 ยท INO Chair, Positioning, Electric
Invacare Corporation
CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.
| Date | Aug 17, 2013 (initiated Jun 18, 2013) |
| Status | Terminated |
| Reason | There is a possibility of elevated temperatures in the seat pad. In addition, the hospital cord set does not agree with the labeling (information in manual). |
| Root cause | Process control |
| Action | Champion Manufacturing plans to initiate this recall within approximately 10 business days after the submission of this report through a phone campaign and notification letters. |
| Quantity | 285 units |
| Distribution | Nationwide distribution: USA including states of: CA, FL, IN, MN, NJ, NY, OH, RI, SC, SD, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.