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Terminated

Philips 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 procedures

FDA Recall Z-0354-2016 · Posted None

Recalling FirmPhilips Medical Systems, Inc.
Recall StatusTerminated
Product CodeOWB
Date Initiated2015-02-03
Date Terminated2017-01-18
Product Quantity22 units

Reason for Recall

Monitor Ceiling Suspension system may fall

Firm Action

Philips sent an Urgent Field Safety Notice letter dated January 8, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. The actuator of all affected systems will be replaced free of charge. All affected customers will be contacted in order to schedule the implementation of this action. For questions contact your local Philips representatice: Technical Support Line: 1-800-722-9377.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130842ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIESPhilips Medical Systems Nederland B.V. · 2013-05-21K041949ALLURA XPER FD10Philips Medical Systems North America Co. · 2004-07-30K033737ALLURA XPER FD20Philips Medical Systems North America, Inc. · 2003-12-09K971365PHILIPS INTEGRIS H5000Philips Medical Systems North America, Inc. · 1997-05-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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