Recall Z-0517-2018— Panoramic Rental Corp.

Name: FDA recall Z-0517-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-14

Class II · Terminated

Class II FDA medical device recall by Panoramic Rental Corp., initiated 2017-07-14, terminated 2018-07-23. It names 2 FDA 510(k) clearances: K882436, K870236. Product: PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3. Reason: The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule..

Recalling firm: Panoramic Rental Corp.
Classification: Class II
Status: Terminated
Initiated: 2017-07-14
Terminated: 2018-07-23
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

PC-1000, PC-1000/Laser1000, Model Numbers 800724-2 & 800724-3

Reason for recall

The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule.

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