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Recall Observatory FDA recall evidence

Device product

Snapshot NIR, REF: KD204

Z-0789-2024

October 30, 2023

Class II

Product summary

Firm
KENT IMAGING, INC.
Event
Event 93624
Status
Ongoing
Classification
Class II
Quantity
57
Official record key
device-enforcement:Z-0789-2024

Official wording

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

Code information: UDI-DI: B376KD2040, Serial Numbers: 204TUC1001, 204TUC1002, 204TUC1003, 204TUC1004, 7204TUC1005, 204TUC1006, 204TUC1007, 204TUC1008, 204TUC1009, 204TUC1010, 204TUC1011, 204TUC1012, 204TUC1013, 204TUC1014, 204TUC1015, 204TUC1024, 204TUC1025, 204TUC1026, 204TUC1028, 204TUC1029, 204TUC1033, 204TUC1036, 204TUC1038, 204TUC1040, 204TUC1041, 204TUC1042, 204TUC1043

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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