FDA-Device2023-05-24Class II
ProxiDiagnost N90 R.1.0
Philips North America
Hazard
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
Sold states
US Nationwide
Affected count
25 systems in total
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
ProxiDiagnost N90 R.1.0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1587-2023Don't want to check this manually?
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