FDA-Device2014-11-19Class II
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Philips Medical Systems, Inc.
Hazard
Faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, can result in a hazardous movement of the C-arc. system.
Sold states
Distributed in the states of IL, and TN, and the countries of Argentina , Australia, Belgium, Denmark, Egypt, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of Netherlands, Norway, Saudi Arabia, Switzerland, United Kingdom, and Viet Nam.
Affected count
2 units
Manufactured in
3000 Minuteman Rd, Andover, MA, United States
Products
Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0182-2015Don't want to check this manually?
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