FDA-Device2021-12-29Class II
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.
Philips North America Llc
Hazard
Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.
Sold states
Worldwide distribution - US Nationwide distribution in the states of DC, GA, MA, TX, VA and the countries of Dominican Republic, INDIA, Japan, Poland, Spain, Taiwan.
Affected count
USA: 5 systems R.O.W.: 15 systems
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, 722028.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0416-2022Don't want to check this manually?
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