Medical device recalls Moderate risk

KENT IMAGING, INC. recalls Snapshot NIR, REF: KD204

Recall date
October 30, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0789-2024
FDA classification
Class II
Brand / firm
KENT IMAGING, INC.
Sold / distributed
Worldwide - US Nationwide distribution in the states of IN, OH, TX, PA, WI, OR, CO, IL, MO, CA, AZ, IA and the countries of Malaysia.

Why it was recalled

Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.

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

What was recalled

Snapshot NIR, REF: KD204

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