Radiometer Medical ApS: Medical Device Recall in 2020 - (Recall #: Z-1836-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 6, 2020

Date Posted: May 6, 2020

Recall Number: Z-1836-2020

Event ID: 85166

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 2 units

Code Information:

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

Distribution Pattern:

US: in the state of California

Voluntary or Mandated:

Voluntary: Firm initiated