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Recall Observatory FDA recall evidence

Device product

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

Z-1836-2020

March 06, 2020

Class II

Product summary

Firm
Radiometer Medical ApS
Event
Event 85166
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1836-2020

Official wording

Reason: 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.

Code information: Serial Numbers: 902-754R2692N002 and 902-754R2692N001

Distribution pattern: US: in the state of California

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.