—#151867

Product

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 product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133292
Affected lot / code info: 1000

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: US: WA OUS: China, Spain, Korea, Republic of, Germany

Timeline

Recall initiated: 2016-12-01
Posted by FDA: 2017-01-20
Terminated: 2017-08-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151867. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.