FDA Device recall Z-0028-2019
Capnostream20 (US) M, Part Number CS08653
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of Capnostream20 (US) M, Part Number CS08653 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-0028-2019 |
| 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 (US) M, Part Number CS08653
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 | B300001095 B300001167 B300001179 B300001180 B300001201 B300001203 B300001215 B300001216 B300001218 B300001195…B300001095 B300001167 B300001179 B300001180 B300001201 B300001203 B300001215 B300001216 B300001218 B300001195 B300001228 B300001364 B300001448 B300001407 B500001573 B500001539 B500001547 B500001548 B500001550 B500001553 B500001559 B500001563 B500001567 B500001571 B500001580 B500001581 B500001582 B500001583 B500001588 B500001592 B500001502 B500001503 B500001506 B500001515 B500001519 B500001523 B500001525 B500001528 B500001529 B500001533 B500001538 B300001446 B500001478 B500001507 B500001518 B500001530 B500001561 B500001568 B500001569 B500001587 B300001360 B300001373 B300001441 B300001500 B500001501 B500001450 B500001461 B500001479 B500001481 B500001484 B500001485 B500001486 B500001487 B500001491 B500001493 B500001494 B500001495 B500001496 B500001497 B500001542 B500001543 B300001268 B500001362 B500001383 B500001399 B500001482 B500001489 B500001490 B500001492 B500001498 B500001537 B500001544 B500001504 B500 |
|---|
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-0028-2019%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.