Aestiva MRI — Class II medical device recall Z-0114-2020
Terminated recall by GE Healthcare, LLC, reported 2019-12-25. Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when conne
| Recall number | Z-0114-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-07-19 |
| Classified | 2019-12-17 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2026-04-13 |
| Quantity | 502 devices |
| Serial numbers | AMTD00105, AMTD00108, AMTD00109, AMTD00110, AMTD00122, AMTE00118, AMTE00125, AMTE00126, AMTE00155, AMTE00156, AMTE00157, AMTE00158, AMTE00159, AMTE00190, AMTE00220, AMTE00221, AMTE00222, AMTE00223, AMTE00225, AMTE00227, AMTE00239, AMTF00108, AMTF00120, AMTF00121, AMTF00122 and 109 more |
Product
Aestiva MRI, Model Numbers: a) 1006-9310-000 b) 1006-9110-000 c) 1006-9023-000 d) 1006-9028-000 e) 1006-9310-000-305077 f) 1006-9310-000-015243 g) 1006-9310-000-017602 h) 1006-9310-000-103785 I) 1006-9310-000-025109 j) 1006-9310-000-009650 k) 1006-9310-000-015224 l) 1006-9310-000-031881 m) 1006-9310-000-031854 n) 1006-9310-000-026571
Reason for recall
Certain Aespire and Aestiva Anesthesia Systems were noted to have a vulnerability to a cyber-attack when connected to the hospital network. An insufficiently secured terminal server may provide an opportunity for a malicious actor that has already penetrated the hospital network to send fraudulent flow sensor correction parameters.
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-0114-2020. 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.