RecallRadar

FDA Device recall Z-0055-2019

CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV

On 2018-10-10 the FDA classified a Class II recall of CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV 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-0055-2019
ClassificationClass II
Statusterminated
Initiated2018-07-31
Published2018-10-10
Last updated2026-09-13 11:54 UTC
CompanyOridion Medical 1987
DistributionUS

Product

CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV

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
ME30160001 ME30160002 ME30160003 ME30160004 ME30160005 ME30160006 ME30160007 ME30160008 ME30160009 ME30160010…ME30160001 ME30160002 ME30160003 ME30160004 ME30160005 ME30160006 ME30160007 ME30160008 ME30160009 ME30160010 ME30160011 ME30160012 ME30160013 ME30160014 ME30160015 ME30160016

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-0055-2019%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.