Medical device recalls Moderate risk

KaVo Dental Technologies LLC recalls cone-beam CT system

Recall date
December 31, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1101-2019
FDA classification
Class II
Brand / firm
KaVo Dental Technologies LLC
Sold / distributed
US distribution in NC

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

cone-beam CT system

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