Events

Rappel de Device Recall Hoyer Hydraulic Patient Lifters

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 Inc..

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
    34153
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0904-06
  • Date de mise en oeuvre de l'événement
    2006-01-06
  • Date de publication de l'événement
    2006-05-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-03-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43199
  • 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
    Lift, Patient, Non-Ac-Powered - Product Code FSA
  • Cause
    A field correction is being conducted on select models of hoyer patient lifts because of hydraulic jack problems that have resulted in patient injury. the possibility exists that the mounting stud located in the bottom of the hydraulic jack could become loose allowing the jack to disengage from the mast of the lift.
  • Action
    A Technical Service Bulletin was distributed along with an Urgent Medical Device Correction letter providing details for checking the mounting stud. UPDATE: Sunrise Medical sent a Second Notice Urgent Medical Device Correction letter, in follow-up to the January 2006 notice, to Dealer/Distributors starting 04/26/06. This Notice updates customers as to what Sunrise''s field correction will be for the Hoyer Model Hydraulic Patient Lifts. The Notice states that use of the affected devices should be discontinued until the lift has been inspected and repaired. Dealers/Distributors that have distributed the product are to notify the user to discontinue use, if possible. If the lift needs to be used then the Dealer/Distributor is to do an interim maintenance.

Device

Device Recall Hoyer Hydraulic Patient Lifters
  • Modèle / numéro de série
    Devices manufactured between July 1, 2001 and December 31, 2004. Model & Serial Number (S/N) Range: C-CB-L2 (S/N''s 0301L0905) , C-HLA (S/N''s: 0110L001 to 0412L0176, 0110J194 to 0204J0795, 0205H0043 to 412H0080 , C-HLA-2T (S/N''s 0206L1296 to 0409L2483, 0206H0945 to 0409H2570), C-HLA-2 (S/N''s 0107L0030 to 0412L0524, 0110J0195 to 0201J1338, 0202H0586 to 412H0082), HML400 (S/N''s 0110L061 to 0412L0127, 0110J098 to 0208J0162, 0112H555 to 0409H2418).
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Canada, Asia, South America
  • Description du dispositif
    Hoyer Hydraulic Patient Lifters model C-CB-L2, C-HLA, C-HLA-2, HML-400, C-HLA-2T and C-HLA-1. Distributed by Sunrise Medical, Inc. 7477 East Dry Creek Parkway, Longmont, CO 80503 USA.
  • Manufacturer
    Joerns Healthcare Inc.

Manufacturer

Joerns Healthcare Inc.
  • Adresse du fabricant
    Joerns Healthcare Inc., 5001 Joerns Dr, Stevens Point WI 54481-5040
  • Source
    USFDA