FDA Device recall Z-0027-2019
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03
- FDA Device
- Class II
- terminated
- Published 2018-10-10
On 2018-10-10 the FDA classified a Class II recall of CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-0027-2019 |
| 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
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03
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 | PA10170221 PA10170222 PA10170224 PA10170226 PA10170227 PA10170238 PA10170240 PA48160004 PA48160009 PA48160011…PA10170221 PA10170222 PA10170224 PA10170226 PA10170227 PA10170238 PA10170240 PA48160004 PA48160009 PA48160011 PA48160012 PA50160014 PA50160017 PA50160021 PA50160023 PA50160024 PA50160025 PA50160026 PA50160027 PA50160028 PA50160029 PA50160030 PA51160034 PA51160035 PA51160036 PA51160037 PA51160038 PA51160039 PA51160040 PA51160041 PA51160042 PA51160043 PA51160044 PA51160045 PA51160046 PA51160047 PA51160048 PA51160049 PA51160050 PA51160051 PA51160053 PA51160054 PA51160055 PA51160056 PA51160057 PA51160058 PA51160059 PA51160060 PA14170880 PA14170881 PA14170882 PA14170883 PA14170884 PA14170885 PA14170886 PA14170887 PA14170888 PA14170889 PA14170890 PA14170891 PA14170892 PA14170893 PA14170894 PA14170896 PA14170898 PA14170899 PA14170900 PA14170901 PA14170902 PA14170904 PA14170905 PA14170906 PA14170907 PA14170908 PA14170909 PA14170910 PA14170911 PA14170912 PA14170913 PA14170914 PA14170915 PA14170916 PA14170917 PA14 |
|---|
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-0027-2019%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.