Class II

Medical Device Recall: Snapshot NIR, REF: KD204

KENT IMAGING, INC. · October 30, 2023

Reason for Recall

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

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

57

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0789-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

KENT IMAGING, INC. Medical Device Recall: Snapshot NIR, REF: KD204 | SafeCheck