FDAFDA · Food and drugs·Recall number Z-0016-2017
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.
Published October 12, 2016 · Recall initiated: August 19, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Panoramic Rental Corp.
- Distributor
- US Nationwide Distribution including Puerto Rico
- Lot
- Model Number(s): 800724-1, 800724-3, Serial numbers 6001 to 19340
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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