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Radiometer Medical ApS recalls ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Recalled May 6, 2020 · FDA recall Z-1836-2020 · Radiometer Medical ApS
Hazard
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. · FDA Class II
Units
2 units
Sold at
US: in the state of California
Description
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.
Product
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Manufacturer(s)
Radiometer Medical ApS
Made in
Denmark
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →