Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images....
FDA Device Recall #Z-2538-2015 — Class II — June 4, 2015
Recall Summary
| Recall Number | Z-2538-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 4, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Panoramic Rental Corp. |
| Location | Fort Wayne, IN |
| Product Type | Devices |
| Quantity | 7885 |
Product Description
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.
Reason for Recall
Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.
Distribution Pattern
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, Taiwan, Turkey, UAE, Uganda, Venezuela, Vietnam, and Virgin Islands.
Lot / Code Information
Model Number: 800724-1, 800724-3; Serial Numbers 6001 to 13885, Manufactured Between 1996 and 2003
Other Recalls from Panoramic Rental Corp.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0517-2018 | Class II | PC-1000, PC-1000/Laser1000, Model Numbers 80072... | Jul 14, 2017 |
| Z-0016-2017 | Class II | Panoramic X-ray Model PC-1000, Laser-1000 packe... | Aug 19, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.