Events

Rappel de STERIS Harmony LL 500/700 Surgical Light

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 Steris 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
    53475
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0414-2010
  • Date de mise en oeuvre de l'événement
    2009-09-11
  • Date de publication de l'événement
    2009-11-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85585
  • 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
    Surgical Lamp - Product Code FTD
  • Cause
    Dr¿ger medical ag & co., kgaa informed steris corporation that they received (4) reported international cases where a welded seam at the joint of the spring-loaded arm of the dr¿ger sola 500/700 surgical light broke as a result of a crack that had slowly developed over time. the steris harmony ll 500/700 surgical light is a private label version of the dr¿ger sola 500/700 surgical light.
  • Action
    The firm sent Urgent Product Correction letters, dated Sept. 11, 2009, to their customers. The letter identified the problem and stated that Drager had supplied STERIS the replacement spring arms and that a STERIS Service Technician would perform the replacement. The letter also stated that the correction would be performed at no charge to the customers. According to the letter, customers would be contacted by their STERIS Service Representative to arrange a convenient time for replacement of potentially affected spring arms. In the meantime, the letter states that customers should use their surgical lights in accordance with the guidelines presented in the Operator's Manual. Questions or concerns regarding the letter should be directed to Barbara Rich at 440-392-7318 or your local STERIS account manager.

Device

STERIS Harmony LL 500/700 Surgical Light
  • Modèle / numéro de série
    Part Number: YG18568; Serial Numbers: Year 2002 - 0111 072 XXXXX to 0111 122 XXXXX; Year 2003-0111 013 XXXXX to 0111 123 XXXXX; Year 2004-0111 014 XXXXX to 0111 124 XXXXX; Year 2005-0111 015 XXXXX to 0111 125 XXXXX; and Year 2006-0111 016 XXXXX to 0111 066 XXXXX - (XXXXX means every 5-digit serial number).
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of AL, AR, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, WA, WI & WY and the country of Canada.
  • Description du dispositif
    STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. || Intended for local illumination of the operating and examination area of the patient in treatment rooms.
  • Manufacturer
    Steris Corp

Manufacturer

Steris Corp
  • Adresse du fabricant
    Steris Corp, 5960 Heisley Rd, Mentor OH 44060
  • Source
    USFDA