Recall Z-2411-2011 ยท FNK Bed, Hydraulic, Adjustable Hospital
Linet Americas Inc
Eleganza 3 Hospital Bed Intended use: AC Powered adjustable Hospital Bed
| Date | Jun 3, 2011 (initiated May 2, 2011) |
| Status | Terminated |
| Reason | Linet has been made aware that there has been breakage of the Mobi-lift handle on a few beds which may cause failure during patient assist use. |
| Root cause | Device Design |
| Action | The firm, Linet America, notified US customers only via phone on May 5, 2011. A follow up "service advisory information" letter dated May 11, 2011 was sent to all customers. The letter described the product, problem and action to be taken. The customers were instructed to remind/retrain staff to ensure that the Mobi-lift handles are always in the stowed position during patient transport and after use, and complete and return the attached Inspection procedure for each affected Eleganza 3 bed via mail to: Linet Americas, 10420-R Harris Oaks Blvd., Charlotte, NC 28269 or fax to: 704-248-5655. Li |
| Quantity | 1601 units |
| Distribution | Worldwide distribution: USA (nationwide) including states of: KY, MA, NC, and NY; and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.