ABL800 FLEX model number 393-800 and 393-801 — Class II medical device recall Z-1836-2020
Ongoing recall by Radiometer Medical ApS, reported 2020-05-06, distributed in CA. Through internal investigation is has been determined that an incorrect component was used within the power su
| Recall number | Z-1836-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer Medical ApS, Bronshoj, N/A, Denmark |
| Recall initiated | 2020-03-06 |
| Classified | 2020-04-30 |
| Reported by FDA | 2020-05-06 |
| Distributed | CA |
| Quantity | 2 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05700693938004 |
| Serial numbers | 902-754R2692N001, 902-754R2692N002 |
| Model numbers | 393-800, 393-801 |
Product
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1836-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.