Recall Z-2538-2015 ยท EHD Unit, X-Ray, Extraoral With Timer
Panoramic Rental Corp.
Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
| Date | Sep 1, 2015 (initiated Jun 4, 2015) |
| Status | Terminated |
| Reason | Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury. |
| Root cause | Equipment maintenance |
| Action | The firm, Panoramic Corporation, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 7/17/2015 via certified mail to customers on 7/20/2015, with response forms for customers to complete and return. The firm previously issued "IMPORTANT SERVICE BULLETIN" notices in 2003 and 2008 via FED-EX. The letter describes the product, problem and actions to be taken. The customers are instructed to select to use several options including replacing the failing part with one containing the safety feature, or trading in their machine for a newer one; discontinue using the devices immediately regardless the |
| Quantity | 7885 |
| Distribution | Worldwide distribution: US (nationwide) all 50 states, including Puerto Rico; and countries of Antigua, Armenia, Aruba, Austria, Canada, China, Colombia, Ecuador, Egypt, England, France, Germany, Greece, Haiti, Honduras, Indonesia, Japan, Kenya, Lithuania, Mexico, Panama, Saudi Arabia, Singapore, Ta |
| FDA record | Open on fda.gov |