Panoramic Rental Corp.
Fort Wayne, IN, US
Panoramic Rental Corp. appears in FDA device records in Fort Wayne, IN. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 3
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0517-2018 | PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3 | The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule. | Class II | Terminated | |
| Z-0016-2017 | 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. | 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. | Class II | Terminated | |
| Z-2538-2015 | 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. | Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
