Aestiva/5 MRI Anesthesia System — Class II medical device recall Z-0311-2021
Ongoing recall by GE Healthcare, LLC, reported 2020-11-11, distributed in AL, AR, AZ, CA, CO, FL, GA, IA…. Flow sensors could have damaged tubes in the form of small punctures or cuts.
| Recall number | Z-0311-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2020-09-17 |
| Classified | 2020-10-30 |
| Reported by FDA | 2020-11-11 |
| Distributed | AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AU, CA, CZ, DE, EE, ES, FR, GB, ID, IL, IN, IT, KW, LV, MY, NI, PA, QA, RU, SG, SI, TH, UA |
| Quantity | 2 devices |
Product
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and 3.0 Tesla shielded MRI devices in a field strength that did not exceed 300 gauss.
Reason for recall
Flow sensors could have damaged tubes in the form of small punctures or cuts.
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-0311-2021. 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.