FDA-Device2023-09-20Class II
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
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-2587-2023More PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls
- FDA-Device2026-06-03Philips Azurion imaging systems recalled for hard drive failure risk affecting imaging functionality
- FDA-Device2026-06-03Philips Allura medical imaging systems recalled for hard drive failure risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for cooling hose degradation risk
- FDA-Device2026-05-27Philips Integris-Allura X-ray systems recalled for cooling unit oil leakage risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for impaired table movement due to control wear
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