Recall Z-0151-2015 ยท FNL Bed, Ac-Powered Adjustable Hospital
Joerns Healthcare
Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device intended for medical purposes. The bed includes a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed.
| Date | Oct 30, 2014 (initiated Sep 24, 2014) |
| Status | Terminated |
| Reason | The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay engaged (locked) after the Care-Lock System has been engaged by stepping on the red (locked) pedal. |
| Root cause | Device Design |
| Action | Joerns sent an Urgent: Medical Device Correction letter dated September 24, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. The firm will provide the customers with a temporary solution kit to safegard the bed until a replacement Care-Lock assembly can be shipped and installed. Customers were instructed to complete the response form. For questions call 800-826-0270. |
| Quantity | 3135 |
| Distribution | Worldwide Distribution: US (nationwide) and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951735 | JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL Joerns Healthcare, Inc., Aug 18, 1995 |