Events

Rappel de Device Recall Pelton & Crane

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 Pelton & Crane Company.

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
    61262
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1177-2012
  • Date de mise en oeuvre de l'événement
    2012-02-20
  • Date de publication de l'événement
    2012-03-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107682
  • 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
    Unit, operative dental - Product Code EIA
  • Cause
    Modification of the pelton & crane spirit 3000 unit disabled the tlc safedrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up.
  • Action
    Pelton & Crane sent an Urgent Medical Device Recall letter dated February 20, 2012 to all affected customers. The letter identifies the affected product, problem and actions to be taken. The letter states that a Pelton & Crane representative will be contacting the customers to schedule a service appointment with the end user of the device so that the affected TLC SAFEdrive circuit board can be replaced and returned to Pelton & Crane. Customers were instructed to complete the attached Recall Acknowledgement/Return Form and fax it to Pelton & Crane, attention Frank Ray, at (704) 587-7250. The letter also requested customers to mail the original Recall Acknowledgement/Return Form in the enclosed self addressed stamped envelope.

Device

Device Recall Pelton & Crane
  • Modèle / numéro de série
    Model #SET30, Catalog #3120, Serial numbers 4096 and 4099.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    (USA) Nationwide Distribution
  • Description du dispositif
    Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273 || Product Usage: || The intended use of the dental operative unit is for supplying power and to serve as a base for other dental devices, such as a dental hand piece, air/water syringe, oral cavity evacuator, a suction operative unit, and other dental devices. The TLC SAFEdrive option is an optional feature that monitors the operation of the high speed hand piece and gives an audible and visual signal to let the user know if the hand piece is potentially damaged or heating up.
  • Manufacturer
    Pelton & Crane Company

Manufacturer

Pelton & Crane Company
  • Adresse du fabricant
    Pelton & Crane Company, 11727 Fruehauf Dr, Charlotte NC 28273
  • Société-mère du fabricant (2017)
    Pelton & Crane Company
  • Source
    USFDA