Events

Retiro De Equipo (Recall) de EasyCare

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Joerns Healthcare.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    69400
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0151-2015
  • Fecha de publicación del evento
    2014-10-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130433
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Causa
    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.
  • Acción
    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
  • Modelo / 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
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and country of: Canada.
  • Descripción del producto
    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
  • Dirección del fabricante
    Joerns Healthcare, 2100 Design Rd, Arlington TX 76014-4593
  • Source
    USFDA