GE Datex-Ohmeda Aisys CS2 Anesthesia System — Class II medical device recall Z-0313-2021
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-0313-2021 |
|---|---|
| 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 | 101 devices |
Product
GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation.
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-0313-2021. 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.