Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial #'s: 51837. 51838, 51900, 51901, 51902, 51903, 51953, 51955, 51973, 51974, 51975 and 51977.
  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:
Ziehm Imaging Inc
Reason for Recall:
Malfunction of the radiation-warning timer and the 3D-specific interval warning. No 5-minute timer dialogs or beeper will occur until the unit is rebooted.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Ziehm Solo, Mobile C-arm for Mobile Fluoroscopic Imaging

Product Codes/Lot Numbers:

Serial #'s: 51837. 51838, 51900, 51901, 51902, 51903, 51953, 51955, 51973, 51974, 51975 and 51977.

Distribution:

Distributed in: US, FL, GA, VA, MA, ME, MI, NY, NJ, PA, RI, IL, TX, AZ, CA, NV, UT, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2643-2016

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