Recall Z-2538-2015— Panoramic Rental Corp.

Name: FDA recall Z-2538-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-04

Class II · Terminated

Class II FDA medical device recall by Panoramic Rental Corp., initiated 2015-06-04, terminated 2017-05-30. It names 2 FDA 510(k) clearances: K882436, K870236. 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..

Recalling firm: Panoramic Rental Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Terminated: 2017-05-30
Firm location: Fort Wayne, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K882436 — LASER - 1000Panoramic Corp.·cleared 1988-08-04
K870236 — PANORAMIC X-RAY MODEL PC-1000Panoramic Corp.·cleared 1987-02-13

K-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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.