# FDA recall Z-1836-2020

> **Radiometer Medical ApS** · Class II · device recall initiated 2020-03-06.

## 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.

## Distribution

US: in the state of California

## Key facts

- **Recall number:** Z-1836-2020
- **Recalling firm:** Radiometer Medical ApS
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-03-06
- **Report date:** 2020-05-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bronshoj, N/A, Denmark

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1836-2020

## Citation

> AI Analytics. FDA recall Z-1836-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1836-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*