Device product
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.
Z-0016-2017
Product summary
- Event
- Event 75017
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,340
- Official record key
device-enforcement:Z-0016-2017
Official wording
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.
Code information: Model Number(s): 800724-1, 800724-3, Serial numbers 6001 to 19340
Distribution pattern: US Nationwide Distribution including Puerto Rico
Derived failure modes
-
Unknown
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.