FDA-Device2023-09-13Class II
MultiDiagnost-Eleva
Hazard
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Sold states
US Nationwide Distribution
Affected count
5432 systems in total
Manufactured in
High Tech Campus 36, N/A, Eindhoven, N/A, Netherlands
Products
MultiDiagnost-Eleva
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2404-2023More 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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