FDA Recall Terminated

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.

Recall: Z-0151-2015 · Initiated September 24, 2014

Recall

Recall Number
Z-0151-2015
Event Number
69400
Firm
Joerns Healthcare
FEI Number
3009402404
Product Code
FNL
Status
Terminated
Root Cause
Device Design
Initiated
September 24, 2014
Posted
October 30, 2014
Terminated
February 1, 2016
Address
2100 Design Rd, Arlington, TX, 76014-4593

Description

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.

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.

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.

Distribution

Worldwide Distribution: US (nationwide) and country of: Canada.

Quantity

3135