Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    00868579000209
  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:
Ortho Kinematics, Inc
Reason for Recall:
This email is to provide notification that, due to a software bug that has been corrected, the Radiological Read Report for the VMA test(s) contained an error.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Vertebral Motion Analyzer (VMA), 2.3.250. Product System, image processing, radiological

Product Codes/Lot Numbers:

00868579000209

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2889-2018

Related Recalls

Ortho Kinematics Inc. sent a Notice of Correction to Released Testing Results, Radiological Read Report for the Vertebral Motion Analyzer (VMA) test because it contained an error. The error occurred due to a software bug that has been corrected.

Jan 11, 2017 Diagnostic Equipment Nationwide View Details →