FDA Device recall Z-0021-2019
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of CAPNOSTREAM 20P (US) N, Part Number CS08651-01 by Oridion Medical 1987, citing the date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0021-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-31 |
| Published | 2018-10-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Oridion Medical 1987 |
| Distribution | US |
Product
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Reason
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Identifiers
| code_info | B632123514 B632123522 B633123527 B633123528 B646113021 B646113026 B646113035 B646113037 B646113040 B646113041…B632123514 B632123522 B633123527 B633123528 B646113021 B646113026 B646113035 B646113037 B646113040 B646113041 B632123520 B646113023 B646113028 B642138118 B642138121 B642138123 B642138125 B643138127 B643138129 B643138131 B643138133 B643138135 B643138137 B643138138 B643138142 B643138143 B643138145 B643138147 B643138148 B643138157 B643138158 B643138159 B643138161 B643138163 B643138164 B646113029 B642138124 B643138149 B643138178 B643138184 B643138185 B643138188 B643138189 B643138194 B643138196 B643138197 B643138199 B643138200 B643138202 B643138203 B643138204 B643138205 B643138206 B643138207 B643138210 B643138211 B643138213 B643138214 B643138227 B643138229 B643138231 B643138234 B643138236 B643138237 B643138248 B644138275 B644138276 B644138280 B644138283 B644138288 B644138289 B644138290 B644138294 B645138308 B645138313 B645138319 B645138328 B645138330 B645138333 B645138334 B645138338 B645138343 B645138347 B645 |
|---|
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-0021-2019%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.