FDA Device recall Z-1836-2020
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
- FDA Device
- Class II
- ongoing
- Published 2020-05-06
On 2020-05-06 the FDA classified a Class II recall of ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 by Radiometer Medical Aps, citing 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 po….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1836-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-03-06 |
| Published | 2020-05-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Radiometer Medical Aps |
| Distribution | CA |
Product
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
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.
Identifiers
| code_info | Serial Numbers: 902-754R2692N002 and 902-754R2692N001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1836-2020%22
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