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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722
Recalled August 28, 2024 · FDA recall Z-2716-2024 · PHILIPS MEDICAL SYSTEMS NEDERLAND B.V
Hazard
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt. · FDA Class II
Units
6 units
Sold at
Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
Description
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
Product
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Manufacturer(s)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →