FDA recall Z-1355-2023

Philips North America Llc · Class II · device

Product

CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031

Reason for recall

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.

Distribution

US Nationwide. Global Distribution.

Key facts

Status: Ongoing
Initiation date: 2021-10-21
Report date: 2023-04-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cambridge, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1355-2023