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FDA (Device enforcement)Recalled 2023-10-30class ii

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

Hazard

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

Details from the source

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. Quantity: 57 Lot/code info: 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

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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