Events

Recall of Device Recall Panoramic Xray Model PC1000, Laser1000

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
    78105
  • Event Risk Class
    Class 2
  • Event Number
    Z-0517-2018
  • Event Initiated Date
    2017-07-14
  • Event Date Posted
    2018-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-07-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158982
  • 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
    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

Device Recall Panoramic Xray Model PC1000, Laser1000
  • Model / Serial
    Serial Numbers: 6001 to 19340
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution including Puerto Rico
  • Product Description
    PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
  • 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