CARESCAPE R860 ventilators with software version 10SP05 Product… — Class II medical device recall Z-2266-2018
Terminated recall by Datex-Ohmeda, Inc., reported 2018-06-27, distributed nationwide. Potential for the display processor to experience an unexpected failure.
| Recall number | Z-2266-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datex-Ohmeda, Inc., Madison, WI, United States |
| Recall initiated | 2017-12-08 |
| Classified | 2018-06-20 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2021-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AU, BD, BE, BG, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, EC, EE, EG, ES, FI, FR, GB, GH, HR, HU, ID, IN, IT, JO, KE, KW, LB, MA, MX, MY, NG, NO, NP, NZ, PE, PH, PK, PL, RU, SA, SG, SV, TH, TR, TW, UY, VN, ZA |
| Serial numbers | 10190157, 10190159, 10191029, 10193770, 10194582, 103721038, 103721045, 103721074, 103721104, 103721436, 103722840, 103725706, 103725811-1, 103725811-2, 103730032, 103737388, 103771194, 103771244, 103785995-1, 103785995-2, 103785995-3, 103785995-4, 103785995-5, 103798917, 103808843 and 475 more |
Product
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: 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. Additional respiratory gas monitoring capabilities are supported through the use of optional GE patient monitoring modules. Not all features are available for all patient types or product configurations. The CARESCAPE R860 ventilator is not a pulmonary function calculation device. The system is designed for facility use, including within facility transport, and should only be used under the orders of a clinician.
Reason for recall
Potential for the display processor to experience an unexpected failure.
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-2266-2018. 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.