RecallRadar

FDA Device recall Z-0042-2019

CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02

On 2018-10-10 the FDA classified a Class II recall of CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS08658-02 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-0042-2019
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, CS08658-02

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
B819140013 B819140014 B819140015 B819140024 B819140030 B819140042 B819140044 B819140049 B820140072 B820140075…B819140013 B819140014 B819140015 B819140024 B819140030 B819140042 B819140044 B819140049 B820140072 B820140075 B820140077 B820140078 B820140079 B820140080 B820140081 B819140003 B819140005 B819140010 B819140016 B819140018 B819140023 B819140025 B819140028 B819140029 B819140035 B819140036 B819140039 B819140047 B819140056 B819140059 B819140062 B820140067 B820140068 B820140071 B820140073 B820140074 B820140082 B819140009 B819140022 B819140027 B819140040 B819140041 B819140046 B819140053 B819140055 B819140057 B819140058 B819140061 B819140064 B819140066 B820140070 B839141804 B839141806 B839141810 B840141817 B840141841 B840141842 B840141836 B840141840 B840141845 B840141846 B848143029 B850143387 B851143493 B851143500 B851143504 B851143505 B851143534 B851143541 B851143548 B851143550 B851143553 B851143556 B851143566 B851143569 B851143578 B802153887 B802153892 B802153936 B802153947 B803153953 B802153812 B802153817 B802

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-0042-2019%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.