Recall Z-1101-2019— KaVo Dental Technologies LLC

Name: FDA recall Z-1101-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-31

Class II · Ongoing

Class II FDA medical device recall by KaVo Dental Technologies LLC, initiated 2018-12-31. It names 2 FDA 510(k) clearances: K180947, K170813. Product: cone-beam CT system. Reason: ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1.

Recalling firm: KaVo Dental Technologies LLC
Classification: Class II
Status: Ongoing
Initiated: 2018-12-31
Firm location: Charlotte, NC, United States

510(k) clearances named in this recall

2 on FDA's record

K180947 — Orthopantomograph OP 3DPalodex Group OY·cleared 2018-06-07
K170813 — ORTHOPANTOMOGRAPH OP 3DPalodex Group OY·cleared 2017-04-07

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

cone-beam CT system

Reason for recall

ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1

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