Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
FDA Recall Z-0923-2017 · Posted 2017-01-20
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Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeIZI
Date Initiated2016-12-01
Date Terminated2017-08-10
Product Quantity1
Reason for Recall
Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
Firm Action
Customers were notified of the recall via letter sent on 12/1/16. The letter explains the issue and the action that Philips plans to take.
Root Cause
Process control
Distribution Pattern
US: WA OUS: China, Spain, Korea, Republic of, Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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