🔍 RecallPedia

Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile

Class I - Dangerous
🏥 Medical Devices Recalled: January 31, 2013 Medtronic Navigation Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Catalog Numbers: 9732719, 9732719R, 9733346, 9733346R, BI-700-00027, BI-700-00027R, BI-700-00027-GER, BI-700-00027-GERR, BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R Units with serial numbers 101 through 564 and unit 580 are affected. Serial numbers 565 and higher are not affected .
  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:
Medtronic Navigation, Inc.
Reason for Recall:
Potential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Medtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile

Product Codes/Lot Numbers:

Product Catalog Numbers: 9732719, 9732719R, 9733346, 9733346R, BI-700-00027, BI-700-00027R, BI-700-00027-GER, BI-700-00027-GERR, BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R Units with serial numbers 101 through 564 and unit 580 are affected. Serial numbers 565 and higher are not affected .

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0926-2013

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