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Philips North America Llc recalls Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascul
Recalled December 29, 2021 · FDA recall Z-0416-2022 · Philips North America
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. · FDA Class II
Units
USA: 5 systems R.O.W.: 15 systems
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Philips North America Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →