Recall Z-0016-2017 ยท EHD Unit, X-Ray, Extraoral With Timer
Panoramic Rental Corp.
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.
| Date | Aug 19, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Panoramic Corporation sent an Urgent Medical Device Correction letter dated August 19, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached form and return to Panoramic. For questions contact Panoramic at correction@pancorp.com or 888-381-2577 Monday through Thursday 8:00 AM to 6:00 PM and Friday 8:00 AM to 5:00 PM EST in order to verify the effectiveness of the safety component. |
| Quantity | 13,340 |
| Distribution | US Nationwide Distribution including Puerto Rico |
| FDA record | Open on fda.gov |