🔍 RecallPedia

NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used for imaging the micro-structure of human tissue. When used with the NvisionVLE Imaging System it provides two-dimensional, cross-sectional, real-time depth visualization.

Class I - Dangerous
🏥 Medical Devices Recalled: April 11, 2018 Ninepoint Medical Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 005196, 005251, 005275
  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:
Ninepoint Medical Inc.
Reason for Recall:
Distal tips of the probes may detach from the probe shaft during use.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

NvisionVLE¿ Low-Profile Optical Probe; Catalog Numbers: 95501-LP and 95501-LP-5; UDI Information: (01)00859591006188(17)180531(10)005196), (01)00859591006188(17)180731(10)005251), (01)00859591006188(17)180930(10)005275) Product Usage: The NvisionVLE Low-Profile Optical Probe is intended to be used for imaging the micro-structure of human tissue. When used with the NvisionVLE Imaging System it provides two-dimensional, cross-sectional, real-time depth visualization.

Product Codes/Lot Numbers:

Lot Numbers: 005196, 005251, 005275

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1781-2018