RecallRadar

FDA Device recall 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

On 2016-10-12 the FDA classified a Class II recall of 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 by Panoramic Rental, citing 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 res….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0016-2017
ClassificationClass II
Statusterminated
Initiated2016-08-19
Published2016-10-12
Last updated2026-09-13 11:54 UTC
CompanyPanoramic Rental
DistributionUS

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.

Identifiers

code_infoModel Number(s): 800724-1, 800724-3, Serial numbers 6001 to 19340

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0016-2017%22

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