Events

Recall of EasyCare

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Joerns Healthcare.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69400
  • Event Risk Class
    Class 2
  • Event Number
    Z-0151-2015
  • Event Date Posted
    2014-10-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130433
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Bed, ac-powered adjustable hospital - Product Code FNL
  • 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.

Device

EasyCare
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and country of: Canada.
  • 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.
  • Manufacturer
    Joerns Healthcare

Manufacturer

Joerns Healthcare
  • Manufacturer Address
    Joerns Healthcare, 2100 Design Rd, Arlington TX 76014-4593
  • Source
    USFDA