Device product
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.
Z-1066-2016
Product summary
- Event
- Event 72325
- Status
- Terminated
- Classification
- Class II
- Quantity
- 196 devices
- Official record key
device-enforcement:Z-1066-2016
Official wording
Reason: Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
Code information: Product Codes: 722026, 722027, 722028, 722029, 722033, 722034, 722035, 722036, 722038, 722039, 722058, 722059 systems with release R8.2.16
Distribution pattern: 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.
Derived failure modes
-
Unknown
Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.