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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

KENT IMAGING, INC.: Snapshot NIR Measurement System Recalled Due to Unresponsive Touchscreens

Agency Publication Date: January 25, 2024
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Summary

KENT IMAGING, INC. has recalled 57 units of the Snapshot NIR tissue oxygenation measurement system (Model KD204) because the device touchscreens may become unresponsive. This defect can prevent healthcare providers from viewing critical oxygenation images during medical assessments. The affected units include specific serial numbers such as 204TUC1001 through 204TUC1043 and were distributed in several U.S. states and Malaysia. Consumers should contact their healthcare provider or the manufacturer for further instructions regarding the repair or replacement of these devices.

Risk

If the touchscreen fails, medical staff may be unable to view oxygenation data or images, which could lead to delays in diagnosis or treatment decisions regarding tissue health.

What You Should Do

  1. Identify if your device is affected by checking the model number and serial number on the back of the unit. The affected product is the Snapshot NIR, Model REF: KD204 with UDI-DI B376KD2040.
  2. Verify your serial number against the list of affected units: 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, or 204TUC1043.
  3. If you have an affected device, contact KENT IMAGING, INC. immediately to discuss the next steps for your unit and to receive further technical instructions.
  4. Contact your healthcare provider if you have concerns about how this device failure may have impacted your clinical assessments.
  5. For additional questions or to report further issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Firm initiated notification via letter.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Snapshot NIR Tissue Oxygenation Measurement System
Model / REF:
KD204
B376KD2040
Lot 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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93624
Status: Active
Manufacturer: KENT IMAGING, INC.
Sold By: Direct distribution
Manufactured In: Canada
Units Affected: 57
Distributed To: Indiana, Ohio, Texas, Pennsylvania, Wisconsin, Oregon, Colorado, Illinois, Missouri, California, Arizona, Iowa

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.