—#141215

Product

Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 BIPLANE R7.9 722013 Allura Xper FD20 BIPLANE R7.10 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 product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033737, K041949, K130842, K971365
Affected lot / code info: System : S/N : Model: 722013 262 Allura Xper FD20 BIPLANE R7.6 722013 422 Allura Xper FD20 BIPLANE R7.7 722013 195 Allura Xper FD20 BIPLANE R7.8 722013 173 Allura Xper FD20 BIPLANE R7.9 722013 225 Allura Xper FD20 BIPLANE R7.10

Why it was recalled

Monitor Ceiling Suspension system may fall

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems, Inc.
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

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.

Timeline

Recall initiated: 2015-02-03
Terminated: 2017-01-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #141215. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.