FDA Device recall Z-0046-2019
Capnostream20 M NICU (CPM), CS08654RN
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of Capnostream20 M NICU (CPM), CS08654RN 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-0046-2019 |
| 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
Capnostream20 M NICU (CPM), CS08654RN
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 | B300001035 B300001077 B300001081 B300001085 B300001086 B300001088 B300001054 B300001067 B300001073 B300001087…B300001035 B300001077 B300001081 B300001085 B300001086 B300001088 B300001054 B300001067 B300001073 B300001087 B300001026 B300001041 B300001058 B300001062 B300001078 B300001079 B300001080 B300001083 B300001084 B300001089 B300001090 B300001091 B300001173 B300001175. B300001217 B300001055 B300001059 B300001134 B300001143 B300001150 B300001151 B300001152 B300001157 B300001174 B300001175 B300001194 B300001197 B300001199 B300001206 B300001209 B300001211 B300001223 B300001225 B300001149 B300001226 B300001227 B300001072 B300001093 B300001153 B300001154 B300001186 B300001192 B300001221 B300001155 B300001156 B300001193 B300001222 B300001305 B300001338 B300001340 B300001345 B300001346 B300001347 B300001348 B300001349 B300001350 B300001353 B300001358 B300001365 B300001367 B300001369 B300001371 B300001374 B300001379 B300001380 B300001382 B300001390 B300001391 B300001401 B300001406 B300001213 B300001240 B300001378 B30 |
|---|
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-0046-2019%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.