Recall Z-0738-2012 ยท FNL Bed, Ac-Powered Adjustable Hospital
Linet Americas Inc
Linet Remote Handset for model Multicare, Eleganza 3 and Eleganza Smart, hospital bed. Product Usage: Positional hospital bed for acute care. The bed is designed for the care and treatment of inpatients at hospitals and is designed for standard and intensive care.
| Date | Jan 13, 2012 (initiated Dec 8, 2011) |
| Status | Terminated |
| Reason | The premature failure of the Remote Handset buttons may result in unintended movement of the bed. |
| Root cause | Nonconforming Material/Component |
| Action | Linet sent a notification letter dated December 9, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken. The letter states that firm Linet has decided to do a voluntary field correction to replace the recalled product. The replacement will be completed by the territory Representative (Linet Employee) who will replace the affected product for each customer personally. The replacement takes approximately 30 seconds and does not require the patient to be moved. For questions or concerns call 704-248-5650. |
| Quantity | 29,252 units |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of: AL, FL, KY, LA, MA, NC, NY, OH and the country of: Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.