Flow-i Anesthesia System Product Usage: The indication for the Flow-i… — Class I medical device recall Z-0804-2016
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2016-03-02, distributed nationwide. Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs)
| Recall number | Z-0804-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2015-12-10 |
| Classified | 2016-02-22 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2016-07-06 |
| Distributed | Nationwide (US) |
| Quantity | 7 units |
| Serial numbers | 2852, 2854, 2855, 2856, 2858 |
| Model numbers | 200, C20, C30, C40 |
Product
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.
Reason for recall
Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues. Only the Model C20 is affected in the US.
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-0804-2016. 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.