FDA-Device2023-09-20Class II
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Hazard
A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiation is possible.
Sold states
Worldwide distribution
Affected count
19,115 systems
Manufactured in
Veenpluis 4-6, Best, Netherlands
Products
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2587-2023Don't want to check this manually?
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