Recall Z-2401-2016 ยท FNL Bed, Ac-Powered Adjustable Hospital
Invacare Corporation
Invacare Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a rest surface with adjustable height from floor and adjustable surface contours.
| Date | Mar 15, 2016 |
| Status | Terminated |
| Reason | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric Bed. They discovered that the Junction Box may omit sparks which could result in a fire in the presence of flammable materials. |
| Root cause | Nonconforming Material/Component |
| Action | Invacare sent an Urgent Medical Device Recall letter dated May 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions call Invacares recall support line at (877) 413-6008, Monday Friday, 8 a.m. 5 p.m. EST, for assistance. |
| Quantity | 3,050 units |
| Distribution | US Nationwide Distribution including DC and PR. Internationally Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.