FDA Device recall Z-0045-2019
Capnostream20 M ADULT ICU (CPM), CS08654RA
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of Capnostream20 M ADULT ICU (CPM), CS08654RA 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-0045-2019 |
| 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 ADULT ICU (CPM), CS08654RA
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 | B3000011359 B300001366 B300001445 B300001452 B300001460 |
|---|
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-0045-2019%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.