Recall Z-0151-2015— Joerns Healthcare

Name: FDA recall Z-0151-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-24

Class II · Terminated

Class II FDA medical device recall by Joerns Healthcare, initiated 2014-09-24, terminated 2016-02-01. It names one FDA 510(k) clearance: K951735. Product: 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..

Recalling firm: Joerns Healthcare
Classification: Class II
Status: Terminated
Initiated: 2014-09-24
Terminated: 2016-02-01
Firm location: Arlington, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K951735 — JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAILJoerns Healthcare, Inc.·cleared 1995-08-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.