🔍 RecallPedia

Snapshot NIR, REF: KD204

Class I - Dangerous
🏥 Medical Devices Recalled: October 30, 2023 KENT IMAGING Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
KENT IMAGING, INC.
Reason for Recall:
Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Snapshot NIR, REF: KD204

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0789-2024