Flow-e Anesthesia System — Class II medical device recall Z-0991-2024
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-0991-2024 |
|---|---|
| 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 | 86 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07325710010457 |
| Serial numbers | 50012, 50030, 50031, 50033, 50034, 50035, 50036, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50046, 50047, 50048, 50051, 50052, 50053, 50054, 50055, 50056, 50057, 50058 and 61 more |
| Model numbers | 6887900 |
Product
Flow-e Anesthesia System, model 6887900
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-0991-2024. 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.