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Philips Medical Systems, Inc. Recall: Philips Healthcare Xper vascular systems R7.6 Model

Philips Medical Systems, Inc. Recall: Philips Healthcare Xper vascular systems R7.6 Model is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Philips Medical Systems, Inc.; Product: Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intend

Recalling firmPhilips Medical Systems, Inc.
ProductPhilips Healthcare Xper vascular systems R7.6 Model : 722134 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 pro
Reason for recallMonitor Ceiling Suspension system may fall
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusTerminated
DistributionWorldwide 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.
Recall initiated20150203
Recall numberZ-0354-2016
Categorydevice
StateMA
CountryUnited States

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