CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a… — Class II medical device recall Z-2883-2020
Terminated recall by GE Healthcare, LLC, reported 2020-09-02. The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate di
| Recall number | Z-2883-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2020-07-14 |
| Classified | 2020-08-24 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2024-09-23 |
| Countries outside the US | AE, AU, BH, BM, CA, DE, EG, ES, FR, HN, IN, IQ, IT, LB, MX, PA, PE, RU, SA, SG, TW, ZA |
| Quantity | 2,277 units |
Product
CARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring of FiO2, airway pressure, flow, and Volume.
Reason for recall
The oxygen sensor for certain CARESCAPE R860 devices has a potential issue that may result in an inaccurate display of FiO2 value from what is being delivered.
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-2883-2020. 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.