Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device intended for medical purposes. The
FDA device recall Z-0151-2015 · posted 2014-10-30 · Terminated
Recall details
- Recalling firm
- Joerns Healthcare
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FNL
- Quantity affected
- 3135
- Distribution
- Worldwide Distribution: US (nationwide) and country of: Canada.
- Date initiated
- 2014-09-24
- Date posted
- 2014-10-30
- Date terminated
- 2016-02-01
- Location
- Arlington, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL (K951735) | Joerns Healthcare, Inc. | 1995-08-18 |