FDAClass IIJanuary 31, 2024

Snapshot NIR recall

Snapshot NIR, REF: KD204

Why was Snapshot NIR recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Snapshot NIR, REF: KD204
Recalling firm
KENT IMAGING, INC.
Quantity
57
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.
Recall date
January 31, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls