FDA-Device2020-05-06Class II
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
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.
Sold states
US: in the state of California
Affected count
2 units
Manufactured in
Akandevej 21, N/A, Bronshoj, N/A, Denmark
Products
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1836-2020Don't want to check this manually?
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