Rappel de Device Recall Panoramic Xray Model PC1000, Laser1000

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 Panoramic Rental 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
    78105
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0517-2018
  • Date de mise en oeuvre de l'événement
    2017-07-14
  • Date de publication de l'événement
    2018-01-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2018-07-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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, x-ray, extraoral with timer - Product Code EHD
  • Cause
    The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule.
  • Action
    On July 14, 2017, Panoramic distributed Urgent Medical Device Correction notices to customers who own and have not taken action as required for the PC-1000 X-ray system machines. This means that your device does not have a critical safety feature that is intended to protect your patients and staff from harm. Customers are encouraged to immediately discontinue use of their machine and follow the instructions in the notice. Customers are encouraged to not resume use of the machine until a certified Panoramic service technician repairs the lift motor. Customers are advised to contact Panoramic to ensure any safety risks associated with the lift motor are identified and addressed. Action Required: (A) If your PC1000 machine is still in service at this location, you must immediately discontinue use and choose one of the following by returning the Acknowledgement Form or contacting the Panoramic Service Team by calling 888-381-2577 Monday through Friday 8 am - 6 pm. 1. An upgraded lift motor assembly at no cost to you; 2. A digital Panoramic rental unit to replace your PC1000, contingent on a signed one year rental contract (subject to availability); or 3. A new digital Panoramic or PanoramicCephalometric unit to replace your PC1000 at a reduced price (starting at $17,995 depending on machine type and subject to availability) (B) If your PC1000 machine is no longer in service or under your control: 4. If the machine is no longer in service, Panoramic will provide free removal of your machine.

Device

  • Modèle / numéro de série
    Serial Numbers: 6001 to 19340
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide distribution including Puerto Rico
  • Description du dispositif
    PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Panoramic Rental Corp., 4321 Goshen Rd, Fort Wayne IN 46818-1201
  • Société-mère du fabricant (2017)
  • Source
    USFDA