Events

Rappel de All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: || Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 || Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 || Model 100580 SGL Trolley, Serial No.''s less than TRS962633 || Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 || Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.

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 Burton Medical Products Corp.

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
    28229
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0589-04
  • Date de mise en oeuvre de l'événement
    2004-02-19
  • Date de publication de l'événement
    2004-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-01-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31412
  • 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
    Device, Medical Examination, Ac Powered - Product Code KZF
  • Cause
    Pivot joint on these ceiling mount lights may fail and lights may fall onto patients.
  • Action
    Firm will ask for subdistribution information from thier distributors via letter on 1/30/2004. Letters will be sent directly to users. Firm will retrofit all sites with suspect units with new pivot assemblies.

Device

All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufacture...
  • Modèle / numéro de série
    See Product Description
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    All Outpatient and Coolspot single ceiling or single track Medical Examination Lights manufactured before August 2000. Products manufactured during or after August 2000 contain a redesigned pivot assembly and are not included in this recall. Affected products include: || Model 100540 Fleximount SGL Ceiling, Serial No.''s less than SC995486 || Model 100740 SGL Ceiling CS II, Serial No''s less than SCCS990745 || Model 100580 SGL Trolley, Serial No.''s less than TRS962633 || Model 100780 SGL Trolley OP II, Serial No.''s less than STOP97417 || Model 102540 SGL Ceiling OP II, Serial No.''s less than SCOP003354.
  • Manufacturer
    Burton Medical Products Corp

Manufacturer

Burton Medical Products Corp
  • Adresse du fabricant
    Burton Medical Products Corp, 21100 Lassen St, Chatsworth CA 91311-4250
  • Source
    USFDA