Events

Rappel de Device Recall Panoramic Xray Model PC1000

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
    71653
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2538-2015
  • Date de mise en oeuvre de l'événement
    2015-06-04
  • Date de publication de l'événement
    2015-09-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138586
  • 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
    Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
  • Action
    The firm, Panoramic Corporation, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 7/17/2015 via certified mail to customers on 7/20/2015, with response forms for customers to complete and return. The firm previously issued "IMPORTANT SERVICE BULLETIN" notices in 2003 and 2008 via FED-EX. The letter describes the product, problem and actions to be taken. The customers are instructed to select to use several options including replacing the failing part with one containing the safety feature, or trading in their machine for a newer one; discontinue using the devices immediately regardless the option you select, and complete and return the attached response card via email to recall@pancorp.com or fax to 260-489-5683. If the machine has been sold or donated to another dental outfit, the customer should notify Panoramic so that they can update their records. When the customer is reached, the firm will confirm whether or not the machine is still in service. Customers with questions may contact 800-654-2027 Monday through Thursday 8:00 AM to 6:00 PM and Friday 8:00 AM to 5:00 PM EST to discuss these options and determine which is best for their practice.

Device

Device Recall Panoramic Xray Model PC1000
  • Modèle / numéro de série
    Model Number: 800724-1, 800724-3; Serial Numbers 6001 to 13885, Manufactured Between 1996 and 2003
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) all 50 states, including Puerto Rico; and countries of Antigua, Armenia, Aruba, Austria, Canada, China, Colombia, Ecuador, Egypt, England, France, Germany, Greece, Haiti, Honduras, Indonesia, Japan, Kenya, Lithuania, Mexico, Panama, Saudi Arabia, Singapore, Taiwan, Turkey, UAE, Uganda, Venezuela, Vietnam, and Virgin Islands.
  • Description du dispositif
    Panoramic X-ray Model PC-1000 || The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
  • Manufacturer
    Panoramic Rental Corp.

Manufacturer

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