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Philips Medical Systems, Inc. recalls Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use i
Recalled December 9, 2015 · FDA recall Z-0351-2016 · Philips Medical Systems
Hazard
Monitor Ceiling Suspension system may fall · FDA Class II
Units
16 units
Sold at
Worldwide Distribution - US Nationwide and the countries of: Canada,Australia, Austria, Brazil, Chile, China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, South Africa, Spain, Switzerland and United Kingdom.
Description
Monitor Ceiling Suspension system may fall
Product
Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thrombolysis and atherectomics), pacemaker Implantations and electrophysiology (EP). Use of the Allura Xper series system in the OR environment is restricted; the system should only be used for endo-vascular procedures. The Philips Integris Allura 9F is intended for diagnostic cardiovascular, vascular and interventional procedures
Manufacturer(s)
Philips Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →