FDA Device recall Z-2738-2018
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrad…
- FDA Device
- Class II
- terminated
- Published 2018-08-15
On 2018-08-15 the FDA classified a Class II recall of The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrad… by Datex Ohmeda, citing the Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2738-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-28 |
| Published | 2018-08-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Datex Ohmeda |
| Distribution | US |
Product
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adult patients weighing 0.25 kg and above.
Reason
The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable.
Identifiers
| code_info | Model Number1506-8600-000, Serial Numbers: CBRX00981 CBRX00984 CBRX00985 CBRX00988 CBRX00990 CBRX00438 CBRX003…Model Number1506-8600-000, Serial Numbers: CBRX00981 CBRX00984 CBRX00985 CBRX00988 CBRX00990 CBRX00438 CBRX00368 CBRX00369 CBRX01033 CBRX01043 CBRX01044 CBRX01048 CBRX01052 CBRX00201 CBRX00208 CBRX00209 CBRX00210 CBRX00212 CBRX00213 CBRX00214 CBRX00215 CBRX00216 CBRX00217 CBRX00749 CBRX00750 CBRX01124 CBRX01131 CBRX01136 CBRX01160 CBRX01162 CBRX01163 CBRX01164 CBRX01165 CBRX01166 CBRX01169 CBRX01017 CBRX01042 CBRX01068 CBRX01069 CBRX01070 CBRX01071 CBRX01083 CBRX01090 CBRX01091 CBRX01097 CBRX01106 CBRX01107 CBRX01112 CBRX01115 CBRX01116 CBRX01117 CBRX01118 CBRX01122 CBRX01125 CBRX01126 CBRX01127 CBRX01128 CBRX01132 CBRX01133 CBRX01134 CBRX01135 CBRX01137 CBRX01151 CBRX01152 CBRX01159 CBRX00983 CBRX01061 CBRX01062 CBRX00266 CBRX00480 CBRX00484 CBRX00488 CBRX00490 CBRX00492 CBRX00346 CBRX00417 CBRX00418 CBRX00421 CBRX00444 CBRX00459 CBRX00505 CBRX00521 CBRX00534 CBRX00535 CBRX00548 CBRX00552 CBRX0055 |
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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-2738-2018%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.