CLASS II ONGOING Device recall · Reported 31 Jan 2024 · FDA Enforcement Report
Snapshot NIR recalled by Kent Imaging
Kent Imaging is recalling Snapshot NIR, distributed nationwide in the US. The recall was initiated on 30 Oct 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0789-2024
- FDA event ID
- 93624
- Recalling firm
- Kent Imaging, Calgary, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Oct 2023
- FDA classified
- 25 Jan 2024
- Reported
- 31 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Oct 2023 | Recall initiated by company | |
| 25 Jan 2024 | Classified by FDA | +87 days |
| 31 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
Product as listed by the FDA
Snapshot NIR, REF: KD204
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoIowaIllinoisMissouriOhioOregonPennsylvaniaTexasWisconsin
Questions about this recall
Why was it recalled?
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
Which lots 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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Kent Imaging
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | SnapshotGLO Wound Imaging Device recalled by Kent Imaging | Kent Imaging | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,929| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rapicide PA Part A High-Level Disinfectant recalled by Steris | Steris | Other | Nationwide |
| Device | CLASS II | NeuroStar Advanced Therapy System recalled by Neuronetics | Neuronetics | Other | Nationwide |
| Device | CLASS II | TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | BD Phoenix Panel Nmic recalled by Becton Dickinson | Becton Dickinson | Device Malfunction | Nationwide |
| Device | CLASS II | BD Phoenix Panel Nmic recalled by Becton Dickinson | Becton Dickinson | Device Malfunction | Nationwide |