FDA Enforcement
Class II
Ongoing
Snapshot NIR, REF: KD204
Recall: Z-0789-2024
·
Reported January 31, 2024
Enforcement
- Recall Number
- Z-0789-2024
- Event ID
- 93624
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- KENT IMAGING, INC.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 31, 2024
- Initiation Date
- October 30, 2023
- Classification Date
- January 25, 2024
- Address
- Suite 300, 1210 8 Street SW, N/A, Calgary, N/A, N/A, Canada
Description
Snapshot NIR, REF: KD204
Reason
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
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
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