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U.S. Department of Health and Human Services

Class 2 Device Recall EasyCare

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  Class 2 Device Recall EasyCare see related information
Date Initiated by Firm September 24, 2014
Date Posted October 30, 2014
Recall Status1 Terminated 3 on February 01, 2016
Recall Number Z-0151-2015
Recall Event ID 69400
510(K)Number K951735  
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
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.
Code Information 901172875, 901173369-901173393, 901173395, 901173417, 901173422-901173423, 901173443-901173447, 901173558-901173560, 901173762-901173776, 901173854-901173857, 901173860-901173861, 901173914, 901174007-901174013, 901174014-901174015, 901174027-901174029, 901174031, 901174033-901174058, 901174162, 901174251-901174302, 901174319-901174320, 901174323, 901174331, 901174342-901174385, 901174389, 901174412-901174426, 901174429-901174430, 901174491-901174521, 901174531-901174541, 901174710-901174716, 901174845, 901174850-901174892, 901174895-901174896, 901174898-901174899, 901174980-901175087, 901175089-901175095, 901175098-901175117, 901175120, 901175123-901175130, 901175185-901175196, 901175202-901175217, 901175225-901175229, 901175246-901175249, 901175341-901175347, 901175359-901175378, 901175380-901175381, 901175383-901175385, 901175387-901175388, 901175392-901175501, 901175513-901175514, 901175533-901175543, 901175549-901175550, 901175553-901175555, 901175571-901175646, 901175688-901175717, 901175719-901175740, 901175745-901175768, 901175792-901175827, 901175988-901175998, 901176002-901176006, 901176008-901176014, 901176033-901176056, 901176059-901176060, 901176065-901176185, 901176187-901176188, 901176190-901176205, 901176223-901176226, 901176230, 901176243-901176254, 901176265-901176281, 901176292-901176311, 901176314-901176316, 901176318-901176323, 901176326-901176331, 901176333-901176340, 901176343, 901176352-901176362, 901176365-901176366, 901176370-901176371, 901176374-901176379, 901176383-901176387, 901176397-901176401, 901176419-901176420, 901176431-901176440, 901176451-901176463, 901176493, 901176495-901176505, 901176513-901176585, 901176644-901176772, 901176317, 901780437-901780453, 901780458-901780460, 901780462-901780574, 901780596-901780722, 901780726-901780735, 901780738-901780744, 901780746-901780756, 901780874-901780910, 901781000-901781435, 901781556-901781570, 901781577-901781610, 901781616-901781625, 901781634-901781684, 901781688-901781726, 901781732-901781733, 901781751-901781766, 901781780-901781875, 901781877, 901781886-901781887, 901781889-901781892, 901781919-901781920, 901781928-901782000, 901782023-901782035, 901782037-901782120, 901782122-901782130, 901782135, 901782157-901782160, 901782172, 901782178-901782192, 901782214-901782218, 901782229-901782233, 901782241-901782249, 901782275-901782283, 901782290-901782291, 901782354-901782364, 901782376-901782383, 901782385-901782387, 901782390-901782414, 901782417-901782428, 901782430, 901782432-901782433, 901782558-901782559, 901782577-901782579, 901782582-901782591, 901782594-901782608, 901782619-901782620, 901782622-901782624, 901782635-901782636, 901782639-901782653, 901782661-901782726, 901782728-901782746, 901782749-901782776, 901782778-901782795, 901782801-901782802, 901782805-901782806, 901782841-901782889, 901782893-901782906, 901782910-901782941, 901782982-901782988, 901782992-901782993, 901782999-901783004, 901783027, 901783121-901783125, 901783130-901783142, 901783144-901783145, 901783158-901783170, 901783172-901783179, 901783194-901783201, 901783233-901783246, 901783318-901783332, 901783337-901783342, 901783345-901783351, 901783358-901783362, 901783364-901783374, 901783392-901783395, 901783398-901783400, 901783408, 901783416-901783418, 901783423-901783429, 901783431, 901783434
Recalling Firm/
Manufacturer		 Joerns Healthcare
2100 Design Rd
Arlington TX 76014-4593
For Additional Information Contact Jennifer Lyle
888-528-8799
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 3135
Distribution Worldwide Distribution: US (nationwide) and country of: Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FNL and Original Applicant = JOERNS HEALTHCARE, INC.
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