FDAFDA · Food and drugs·Recall number Z-0568-2014
Ziehm Vision RFD 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
- 20006 20025 20142 20185 20216 20231 20015 20026 20151 20186 20217 20236 20016 20027 20153 20189 20225 20018 20031 20166 20198 20227 20019 20139 20184 20199 20228
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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