Events

Recall of Device Recall Panoramic Corp. PC1000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Panoramic Rental Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75017
  • Event Risk Class
    Class 2
  • Event Number
    Z-0016-2017
  • Event Initiated Date
    2016-08-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149123
  • Notes / Alerts
    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.
  • Extra notes in the data
    Unit, x-ray, extraoral with timer - Product Code EHD
  • Reason
    Panoramic corporation is performing a voluntary medical device correction on certain pc-1000 x-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.
  • Action
    Panoramic Corporation sent an Urgent Medical Device Correction letter dated August 19, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached form and return to Panoramic. For questions contact Panoramic at correction@pancorp.com or 888-381-2577 Monday through Thursday 8:00 AM to 6:00 PM and Friday 8:00 AM to 5:00 PM EST in order to verify the effectiveness of the safety component.

Device

Device Recall Panoramic Corp. PC1000
  • Model / Serial
    Model Number(s): 800724-1, 800724-3, Serial numbers 6001 to 19340
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution including Puerto Rico
  • Product Description
    Panoramic X-ray Model PC-1000, Laser-1000 packed in a crate || Product Usage: || The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser1000 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.
  • Manufacturer Address
    Panoramic Rental Corp., 4321 Goshen Rd, Fort Wayne IN 46818-1201
  • Manufacturer Parent Company (2017)
    Young Innovations Inc.
  • Source
    USFDA