Events

Rappel de Device Recall Volker 2080, 2082, S 280 and S 282

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 Hill-Rom, 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
    74615
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2376-2016
  • Date de mise en oeuvre de l'événement
    2016-06-14
  • Date de publication de l'événement
    2016-08-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148050
  • 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 current construction of the side rail latch may not be able to support the full patient weight and may give way allowing the side rail to abruptly lower and the patient to fall, potentially resulting in harm. to date there has been one report of a related injury.
  • Action
    Hill-Rom sent an URGENT: MEDICAL DEVICE CORRECTION letter dated June 14, 2016 to the affected US and Canadian customers via email and courier, international customers. The letter included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The letter requests the number of beds in the consignees possession so that repair kits can be provided. If you have any questions regarding this safety notice, contact Hill-Rom Technical Support at 1-800-445-3720, your distributor, your Hill-Rom representative or contact us on www.hill-rom.com.

Device

Device Recall Volker 2080, 2082, S 280 and S 282
  • Modèle / numéro de série
    All beds (serial numbers) in the 2080, 2082, S 280 and S 282 series are affected by this field action except for those without siderails. The models are as follows: 2080, 2082, 2080 C, 2080 E, 2080 FS, 2080 K, 2080 LP, 2080 MA, 2080 MB, 2080 S, 2080 SL, 2080 SONDER, 2082 SONDER, S280, S280 SONDER, S282, S282 SONDER.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of: Canada, AUSTRALIA, CHINA, HONG KONG, THAILAND, POLAND, RUSSIAN FEDERATION, SLOVENIA, UNITED ARAB EMIRATES, AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, ICELAND, IRELAND, ISRAEL, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, SPAIN, SWITZERLAND, and UNITED KINGDOM.
  • Description du dispositif
    Volker 2080, 2082, S 280 and S 282 series beds with lateral release button. || A/C Powered Adjustable Hospital Bed || Product Usage: || Volker model 2080/3010/3080 nursing beds are intended for the care of residents in rooms in nursing homes, in residential homes for the elderly and in suitable rooms in private residences. They may not, however, be used for transportation purposes. Any deviation from this use is expressly excluded from possible liability claims.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Adresse du fabricant
    Hill-Rom, Inc., 1069 State Road 46 E, Batesville IN 47006-7520
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA