🔍 RecallPedia

Neoprobe GDS Control Unit, Model Number NPCU3

Class I - Dangerous
🏥 Medical Devices Recalled: September 7, 2020 Devicor Medical Products Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    UDI: 00841911100317; Serial Numbers: 122066557 122066558 122066559 122066560 122066561 122666652 123066667 123066668 123066669 123366695 123366696 123366697 123366698 123366699 123366700 123366701 123366702 123266693 123266694 134467282 143367591 144867780 145067796 150367828 150367829 150367840 150467866 150467867 150367830 150367831 150367832 150967913 150967914 151067915 151067916 151067917 151267970 151267971 151267972 151267973 151267974 185269399 185269403 190269421 190469433 190469430 190469428 150467871 150467869
  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:
Devicor Medical Products Inc
Reason for Recall:
It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Neoprobe GDS Control Unit, Model Number NPCU3

Product Codes/Lot Numbers:

UDI: 00841911100317; Serial Numbers: 122066557 122066558 122066559 122066560 122066561 122666652 123066667 123066668 123066669 123366695 123366696 123366697 123366698 123366699 123366700 123366701 123366702 123266693 123266694 134467282 143367591 144867780 145067796 150367828 150367829 150367840 150467866 150467867 150367830 150367831 150367832 150967913 150967914 151067915 151067916 151067917 151267970 151267971 151267972 151267973 151267974 185269399 185269403 190269421 190469433 190469430 190469428 150467871 150467869

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0070-2021

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