FDA-Device2023-04-19Class II
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Philips North America Llc
Hazard
If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from the cabinet, or hear a popping sound coming from the cabinet.
Sold states
US Nationwide. Global Distribution.
Affected count
512 units
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1355-2023Don't want to check this manually?
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