FDA Device recall Z-0804-2016
Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while contro…
- FDA Device
- Class I
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class I recall of Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while contro… by Maquet Cardiovascular Us Sales, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0804-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-12-10 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | US |
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
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.
Identifiers
| code_info | Model numbers: C20, C30 and C40 (Only Model # C20 for US) Part numbers: 66 77 200 (US Only), 66 77 300 and 66 77 40…Model numbers: C20, C30 and C40 (Only Model # C20 for US) Part numbers: 66 77 200 (US Only), 66 77 300 and 66 77 400 Serial numbers (2743, 2852, 2854, 2855, 2856, 2858 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0804-2016%22
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