Snapshot NIR — Class II medical device recall Z-0789-2024
Ongoing recall by KENT IMAGING, INC., reported 2024-01-31, distributed nationwide. Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxyge
| Recall number | Z-0789-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | KENT IMAGING, INC., Calgary, N/A, Canada |
| Recall initiated | 2023-10-30 |
| Classified | 2024-01-25 |
| Reported by FDA | 2024-01-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | MY |
| Quantity | 57 |
| Serial numbers | 204TUC1001, 204TUC1002, 204TUC1003, 204TUC1004, 204TUC1006, 204TUC1007, 204TUC1008, 204TUC1009, 204TUC1010, 204TUC1011, 204TUC1012, 204TUC1013, 204TUC1014, 204TUC1015, 204TUC1024, 204TUC1025, 204TUC1026, 204TUC1028, 204TUC1029, 204TUC1033, 204TUC1036, 204TUC1038, 204TUC1040, 204TUC1041, 204TUC1042 and 2 more |
| Model numbers | KD204 |
Product
Snapshot NIR, REF: KD204
Reason for recall
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0789-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.