Events

Rappel de Device Recall Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07)

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 Reliance Medical Products 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
    79601
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1318-2018
  • Date de mise en oeuvre de l'événement
    2017-12-06
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162749
  • 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
    Refractor, manual, non-powered, including phoropter - Product Code HKN
  • Cause
    Product has been found with a missing washer, retaining ring, and/or stop screw. recalling firm was notified by distributor that refractor suspension arm fell on a patient s lower torso along with the arm housing.
  • Action
    Recalling firm sent letter to customers via certified mail for US customers and via regular mail to foreign customers. Verify product has the presence of the one or more of the three parts: Refractor Suspension Arm missing Screw, Washer and/or Retaining Ring (Snap Ring) that may be missing, and to assure it is functioning properly. For further questions, please call (513) 398-3937

Device

Device Recall Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07)
  • Modèle / numéro de série
    Model Number: 525004, 05 and 525006, 07
  • Classification du dispositif
    Ophthalmic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA(nationwide) Distribution to the states of : NJ, CA, OH, VA, MA, MN, IL , UT, TN, AR, LA, AZ, PA, TX, IA and HI., and to the countries of : Costa Rica, Jamaica, South Africa, New Zealand, South Korea, Dubai, Saudi Arabia and Jordan.
  • Description du dispositif
    Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) || The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a refractor.
  • Manufacturer
    Reliance Medical Products Inc

Manufacturer

Reliance Medical Products Inc
  • Adresse du fabricant
    Reliance Medical Products Inc, 3535 Kings Mills Rd, Mason OH 45040-2303
  • Société-mère du fabricant (2017)
    Metall Zug AG
  • Source
    USFDA