FDA Device recall Z-2266-2018
CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical vent…
- FDA Device
- Class II
- terminated
- Published 2018-06-27
On 2018-06-27 the FDA classified a Class II recall of CARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical vent… by Datex Ohmeda, citing potential for the display processor to experience an unexpected failure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2266-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-08 |
| Published | 2018-06-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Datex Ohmeda |
| Distribution | US |
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
Potential for the display processor to experience an unexpected failure.
Identifiers
| code_info | Lot / Serials #'s: 103841473, 103725811-1, 103725811-2, CBRW01546, CBRW01547, CBRU02110, CBRV00344, CBRV02569, CBRV0029…Lot / Serials #'s: 103841473, 103725811-1, 103725811-2, CBRW01546, CBRW01547, CBRU02110, CBRV00344, CBRV02569, CBRV00298, 103721045, 103808843, CBRV03050, CBRV03054, CBRV03056, CBRV03063, CBRV03064, CBRV03071, CBRV03072, CBRV03073, CBRW00417, CBRW00419, CBRW00424, CBRW00441, CBRW00443, CBRW00458, CBRW00460, CBRW00461, CBRW02306, CBRW02627, CBRW02629, 103721436, CBRU02450, CBRW01735, CBRW01044, CBRW01048, CBRW01049, CBRW01051, CBRW01052, CBRW01053, CBRW01056, CBRW01057, CBRW01059, CBRW01061, CBRW01062, CBRW01063, CBRW01075, CBRW01076, CBRW01077, CBRW01232, CBRW01814, CBRW01410, CBRW01412, 103798917, CBRW01918, CBRV02578, CBRW02442, CBRW02449, CBRW01830, CBRW01833, CBRW01838, CBRW01839, CBRW01849, CBRW01860, CBRW01889, CBRW01895, CBRW01896, CBRW01897, CBRW01898, CBRW01899, CBRW01900, CBRW01902, CBRW01903, CBRW01904, CBRW01905, CBRW01906, CBRW01909, CBRW01932, CBRV01459, 103730032, 103721104, CBRW01244, CBRW02420, CBRW01347, 103771244, CBRW02661, CBRU02452, 11495021, 7017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2266-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.