Recall Z-0016-2017— Panoramic Rental Corp.
Class II · Terminated
Class II FDA medical device recall by Panoramic Rental Corp., initiated 2016-08-19, terminated 2018-01-11. It names 2 FDA 510(k) clearances: K882436, K870236. Product: 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.. 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..
- Recalling firm
- Panoramic Rental Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-19
- Terminated
- 2018-01-11
- Firm location
- Fort Wayne, IN, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.