GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard — Class I medical device recall Z-0463-2019
Terminated recall by GE Healthcare, LLC, reported 2018-12-12, distributed nationwide. The ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result,
| Recall number | Z-0463-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2018-10-05 |
| Classified | 2018-11-30 |
| Reported by FDA | 2018-12-12 |
| Terminated | 2024-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BO, BR, CA, CH, CL, CN, CO, DE, DO, EC, EG, ES, FI, FR, GB, GR, HN, HU, ID, IN, IQ, IT, JP, KR, KW, LB, LV, MX, MY, NG, NI, NL, NO, NP, PA, PE, PH, PK, PL, PT, RO, RU, SA, SG, SV, TR, TW, UY, VN, ZA |
| Lot numbers | 17/00951, 17/01174, 17/01937, 17/01994, 17/02372, 17/02393, 18/00126, 18/00127, 18/00128, 18/00129, 18/00130 |
Product
GE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above. 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 ventilator Inspiratory Safety Guard (ISG) may disconnect from the breathing circuit pathway. As a result, this could create a loss of ventilation which may lead to inadequate oxygenation for patients, increasing the possibility of hypoxia.
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-0463-2019. 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.