Class II — Radiometer Medical ApS
| Recalling firm | RADIOMETER MEDICAL APS |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004 |
| Quantity | 2 units |
| Distribution | US: in the state of California |
| Initiated | 2020-03-06 |
| Classified | 2020-04-30 |
| Recall number | Z-1836-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Radiometer Medical ApS (Z-1836-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85166/
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