Flow-i C40 Anesthesia System — Class II medical device recall Z-0989-2024
Ongoing recall by Getinge Usa Sales Inc, reported 2024-02-14, distributed nationwide. Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remot
| Recall number | Z-0989-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Usa Sales Inc, Wayne, NJ, United States |
| Recall initiated | 2023-12-11 |
| Classified | 2024-02-06 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Quantity | 16 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07325710001318 |
| Serial numbers | 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446, C40 |
| Model numbers | 6677400 |
Product
Flow-i C40 Anesthesia System, model 6677400
Reason for recall
Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.
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-0989-2024. 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.