Events

Alerte Ou Avis De Sécurité sur Standard Sling Bar 450 (Spreader bar)

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Liko.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2013/051
  • Numéro de l'événement
    CON296382
  • Date
    2013-07-09
  • Date de publication de l'événement
    2013-07-09
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON296382?tabName=allTabs
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    Risk of serious injury to a patient, caregiver or bystander could result from tripping or otherwise falling on to the sling bar.   the sling hook on the end of the sling bar could pierce a body structure such as the head, shoulder, or groin.
  • Action
    Identify affected Sling Bars, see manufacturer’s Field Safety Notice (FSN). Confirm receipt of the FSN and return the completed manufacturer’s Response Form. Contact manufacturer to arrange to have sling bar safety covers fitted on affected devices.

Device

Standard Sling Bar 450 (Spreader bar)
  • Modèle / numéro de série
  • Description du dispositif
    Overhead and Mobile Patient Hoists: Standard Sling Bar 450 (Spreader bar). Specific models numbers. Manufactured By Liko (A Hill-Rom Company). Affected Devices: Standard Sling Bar 450, product numbers: 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043, or 5019013. Distributed from January 1980 to November 2012 inclusive The above sling bar product numbers may be assembled with Golvo 1000, 3000 and 7000 series lifts, Viking M, Viking L, LikoLight 100 & 125, Caroli 101 and Uno 100, 101 & 102.
  • Manufacturer
    Liko

Manufacturer

Liko