BEUDAMED
    FDA Recall Terminated

    PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3

    Recall: Z-0517-2018 · Initiated July 14, 2017

    Recall

    Recall Number
    Z-0517-2018
    Event Number
    78105
    Firm
    Panoramic Rental Corp.
    FEI Number
    1832462
    Product Code
    EHD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 14, 2017
    Posted
    January 9, 2018
    Terminated
    July 23, 2018
    Address
    4321 Goshen Rd, Fort Wayne, IN, 46818-1201

    Description

    PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3

    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.

    Distribution

    US Nationwide distribution including Puerto Rico

    Quantity

    13,340 units