FDA recall Z-0789-2024

KENT IMAGING, INC. · Class II · device

Product

Snapshot NIR, REF: KD204

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.

Key facts

Status
Ongoing
Initiation date
2023-10-30
Report date
2024-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Calgary, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0789-2024