Recall Z-0517-2018 ยท EHD Unit, X-Ray, Extraoral With Timer
Panoramic Rental Corp.
PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3
| Date | Jan 9, 2018 (initiated Jul 14, 2017) |
| Status | Terminated |
| Reason | The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule. |
| Root cause | Device Design |
| 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 Panoram |
| Quantity | 13,340 units |
| Distribution | US Nationwide distribution including Puerto Rico |
| FDA record | Open on fda.gov |