ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Through internal investigation is has been determined that an incorrect component was used within the power supply. The incorrect component may cause a short circuit within the power supply resulting in a delay in treatment. The delay could result in a range of risk from cyanosis and low blood pressure to cardiac arrhythmias and severe impairment of cardiac function.
US: in the state of California
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1836-2020