RecallRadar

FDA Device recall Z-0043-2019

CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03

On 2018-10-10 the FDA classified a Class II recall of CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03 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-0043-2019
ClassificationClass II
Statusterminated
Initiated2018-07-31
Published2018-10-10
Last updated2026-09-13 11:54 UTC
CompanyOridion Medical 1987
DistributionUS

Product

CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-03

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
PA14170895 PA14170897 PA14170903 PA14170930 PA14170937 PA14170944 PA14170952 PA14170954 PA14170956 PA14170961…PA14170895 PA14170897 PA14170903 PA14170930 PA14170937 PA14170944 PA14170952 PA14170954 PA14170956 PA14170961 PA14170962 PA14170963 PA14170964 PA14170965 PA14170966 PA14170967 PA14170968 PA14170969 PA14170970 PA14170971 PA14170973 PA14170974 PA14170975 PA14170976 PA14170977 PA14170978 PA14170979 PA14170980 PA14170981 PA14170982 PA14170983 PA14170984 PA14170985 PA14170986 PA14170987 PA14170988 PA14170989 PA14170990 PA14170991 PA14170992 PA14170993 PA14170994 PA14170995 PA14170996 PA14170997 PA14170998 PA14170999 PA14171000 PA15171001 PA15171002 PA15171003 PA15171004 PA15171005 PA15171006 PA15171007 PA15171008 PA15171009 PA15171010 PA15171011 PA15171012 PA15171013 PA15171014 PA15171015 PA15171016 PA15171017 PA15171018 PA15171019 PA15171020 PA15171021 PA15171022 PA15171023 PA15171024 PA15171025 PA15171026 PA15171027 PA15171028 PA15171029 PA15171030 PA15171031 PA15171032 PA15171033 PA15171034 PA15171035 PA15

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-0043-2019%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.