medical Class II Updated 2020-05-06

Radiometer Medical ApS recalls ABL800 FLEX model number 393-800 and 393-801, UDI:(01)057006

Recalled Product

ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004

Hazard / Issue

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.

Issued by

FDA

Distribution: US: in the state of California
Lot/Code Info: Serial Numbers: 902-754R2692N002 and 902-754R2692N001
View official government recall

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