FDA-Device2017-02-01Class II
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).
Philips Electronics North America Corporation
Hazard
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.
Sold states
US: WA OUS: China, Spain, Korea, Republic of, Germany
Affected count
1
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0923-2017Don't want to check this manually?
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