FDA-Device2024-08-28Class II
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard
A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.
Sold states
Worldwide - US Nationwide distribution in the states of IL and OR. The countries of Hungary, Ireland, Poland, UK.
Affected count
6 units
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2716-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief