RecallRadar

FDA Device recall Z-0029-2019

Capnostream20 (US) M W/PRINTER, Part Number CS08659

On 2018-10-10 the FDA classified a Class II recall of Capnostream20 (US) M W/PRINTER, Part Number CS08659 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

AgencyFDA Device
Recall numberZ-0029-2019
ClassificationClass II
Statusterminated
Initiated2018-07-31
Published2018-10-10
Last updated2026-09-13 11:54 UTC
CompanyOridion Medical 1987
DistributionUS

Product

Capnostream20 (US) M W/PRINTER, Part Number CS08659

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
B300001010 B300001017 B300001011 B300001056 B300001135 B300001270 B300001318 B300001326 B300001439 B300001396…B300001010 B300001017 B300001011 B300001056 B300001135 B300001270 B300001318 B300001326 B300001439 B300001396 B300001422 B300001323 B300001327 B300001328 B300001332 B300001264 B500001508 B500001470 B500001471 B500001509 B500001524 B300001404 B300001398 B300001377 B300001386 B300001107 B300001212 B300001308 B300001314 B300001016 B300001128 B300001235 B300001285 B300001291 B300001258 B500001647 B500001731 B500001711 B500001723 B500001735 B300001412 B500001717 B500001732 B300001137 B300001146 B300001147 B300001352 B300001393 B300001408 B500001517 B300001302 B500001827 B500001830 B500001832 B500001839 B500001845 B500001856 B500001858 B500001859 B500001860 B500001861 B500001864 B500001866 B500001868 B500001869 B500001871 B500001875 B500001876 B500001879 B500001881 B500001882 B500001884 B500001886 B500001887 B500001888 B500001889 B500001891 B500001895 B500001896 B500001904 B500001906 B500001907 B500001908 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-0029-2019%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.