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Terminated

Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).

FDA Recall Z-0924-2017 · Posted 2017-01-20

Recalling FirmPhilips Electronics North America Corporation
Recall StatusTerminated
Product CodeOWB
Date Initiated2016-12-01
Date Terminated2017-08-10
Product Quantity2

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

Official Source

View FDA Recall →

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

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