Events

Rappel de EasyCare

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Joerns Healthcare.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    69400
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0151-2015
  • Date de publication de l'événement
    2014-10-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130433
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Bed, ac-powered adjustable hospital - Product Code FNL
  • Cause
    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
  • Modèle / numéro de série
    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
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and country of: Canada.
  • Description du dispositif
    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
  • Adresse du fabricant
    Joerns Healthcare, 2100 Design Rd, Arlington TX 76014-4593
  • Source
    USFDA