Z-0016-2017 Class II Terminated
FDA device recall Z-0016-2017 was initiated by Panoramic Rental Corp. on August 19, 2016 and is designated Class II. Reason for recall: 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 tr… The recall status is terminated (terminated January 11, 2018). Affected quantity: 13,340.
Recall Details
- Product Type
- Devices
- Report Date
- October 12, 2016
- Initiation Date
- August 19, 2016
- Termination Date
- January 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,340
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide Distribution including Puerto Rico
Code Information
Model Number(s): 800724-1, 800724-3, Serial numbers 6001 to 19340