FDAFDA · Food and drugs·Recall number Z-0563-2014
Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile Fluoroscopic Imaging
Published January 1, 2014 · Recall initiated: November 21, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ziehm Imaging Inc
- Distributor
- USA (Nationwide) Distribution including the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MT, MA, MD, MI, MN, MN, MO,MS, NC ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Hawaii.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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