FDA Device recall Z-0047-2019
Capnostream20 (INTL) M W/PRINTER, CS08660
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of Capnostream20 (INTL) M W/PRINTER, CS08660 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-0047-2019 |
| 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 (INTL) M W/PRINTER, CS08660
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 | B300001031 B300001047 B300001049 B300001052 B300001065 B300001453 B300001454 B300001468 B300001130 B300001325…B300001031 B300001047 B300001049 B300001052 B300001065 B300001453 B300001454 B300001468 B300001130 B300001325 B500001762 B500001843 B500001892 B500001915 B500001945 B500002146 B500002103 B500002150 B500002132 B502123108 B523123180 B523123182 B523123186 |
|---|
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-0047-2019%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.