FDAFDA · Food and drugs·Recall number Z-1066-2016
Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology (EP). The Allura Xper FD2O, Allura Xper FD2O/10 and Allura Xper FD2O/20 is intended for: Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures.
Published March 16, 2016 · Recall initiated: October 1, 2015
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
Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Electronics North America Corporation
- Distributor
- US Nationwide in the states of : AK, AL, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NY, OH, OR, PA, TN, TX, UT, WI, WV and the country of Canada.
- Lot
- Product Codes: 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059 systems with release R8.2.16
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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