RecallRadar

FDA Device recall Z-2538-2015

Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images

On 2015-09-09 the FDA classified a Class II recall of Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images by Panoramic Rental, citing jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2538-2015
ClassificationClass II
Statusterminated
Initiated2015-06-04
Published2015-09-09
Last updated2026-09-13 11:53 UTC
CompanyPanoramic Rental
DistributionUS

Product

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

Jackscrew nut part failure potentially leading to device malfunction and patient/operator injury.

Identifiers

code_infoModel Number: 800724-1, 800724-3; Serial Numbers 6001 to 13885, Manufactured Between 1996 and 2003

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2538-2015%22

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