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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