FDAFDA · Food and drugs·Recall number Z-0789-2024
Snapshot NIR, REF: KD204
Published January 31, 2024 · Recall initiated: October 30, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- KENT IMAGING, INC.
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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