Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    50104 50694 50704 50714 50812 50875 50105 50695 50705 50785 50813 50901 50106 50696 50706 50786 50815 50902 50107 50697 50707 50802 50817 50925 50108 50698 50708 50803 50818 50926 50109 50699 50709 50804 50819 50927 50653 50700 50710 50805 50820 50937 50663 50701 50711 50808 50872 50939 50671 50702 50712 50810 50873 50693 50703 50713 50811 50874
  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:
Engineering change in 2006 resulted in a minor non-conformity of their devices. Specifically the emergency switch was changed from a standard component to just an option on the devices.
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 C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging

Product Codes/Lot Numbers:

50104 50694 50704 50714 50812 50875 50105 50695 50705 50785 50813 50901 50106 50696 50706 50786 50815 50902 50107 50697 50707 50802 50817 50925 50108 50698 50708 50803 50818 50926 50109 50699 50709 50804 50819 50927 50653 50700 50710 50805 50820 50937 50663 50701 50711 50808 50872 50939 50671 50702 50712 50810 50873 50693 50703 50713 50811 50874

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0563-2014

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