CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report

Capnostream 20p (intl) N W/printer recalled by Oridion Medical 1987

Oridion Medical 1987 is recalling Capnostream 20p (intl) N W/printer, distributed nationwide in the US. The recall was initiated on 31 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesB638137550 B638137552 B638137553 B638137554 B638137556 B638137559 B638137562 B638137567 B638137568 B638137569 B638137572 B638137573 B638137574 B638137575 B638137576 B638137578 B638137581 B638137584 B638137587 B638137589 B638137594 B638137597 B638137598 B642138045 B642138050 B642138053 B642138054 B642138057 B642138061 B642138064 B642138073 B642138076 B642138077 B642138079 B642138080 B642138081 B642138085 B642138094 B642138097 B642138099 B642138107 B642138108 B642138109 B638137571 B616149193 B616149199 B616149200 B616149204 B616149209 B616149213 B616149216 B616149217 B616149218 B616149233 B625140084 B625140085 B625140087 B625140088 B625140089 B625140090 B625140092 B625140093 B625140094 B625140096 B625140098 B625140101 B625149944 B625149945 B625149946 B625149947 B625149948 B625149950 B625149951 B625149952 B625149953 B625149955 B625149956 B625149957 B625149958 B625149959 B625149960 B625149961 B625149962 B625149963 B625149964 B625149965 B625149966 B625149967 B625149970 B625149971 B625149972 B625149973 B625149974 B625149975 B625149977 B625149978 B625149979 B625149981 B625149982 B625149983 B625149984 B625149985 B625149986 B625149988 B625149989 B625149990 B625149991 B625149992 B625149994 B625149996 B625149997 B625149999 B625149976

Quantity recalled113

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0041-2019
FDA event ID: 80895
Recalling firm: Oridion Medical 1987, Jerusalem
Classification: Class II
Status: Terminated
Recall initiated: 31 Jul 2018
FDA classified: 3 Oct 2018
Reported: 10 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

31 Jul 2018	Recall initiated by company
3 Oct 2018	Classified by FDA	+64 days
10 Oct 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01

Where it was distributed

The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

B638137550 B638137552 B638137553 B638137554 B638137556 B638137559 B638137562 B638137567 B638137568 B638137569 B638137572 B638137573 B638137574 B638137575 B638137576 B638137578 B638137581 B638137584 B638137587 B638137589 B638137594 B638137597 B638137598 B642138045 B642138050 B642138053 B642138054 B642138057 B642138061 B642138064 B642138073 B642138076 B642138077 B642138079 B642138080 B642138081 B642138085 B642138094 B642138097 B642138099 B642138107 B642138108 B642138109 B638137571 B616149193 B616149199 B616149200 B616149204 B616149209 B616149213 B616149216 B616149217 B616149218 B616149233 B625140084 B625140085 B625140087 B625140088 B625140089 B625140090 B625140092 B625140093 B625140094 B625140096 B625140098 B625140101 B625149944 B625149945 B625149946 B625149947 B625149948 B625149950 B625149951 B625149952 B625149953 B625149955 B625149956 B625149957 B625149958 B625149959 B625149960 B625149961 B625149962 B625149963 B625149964 B625149965 B625149966 B625149967 B625149970 B625149971 B625149972 B625149973 B625149974 B625149975 B625149977 B625149978 B625149979 B625149981 B625149982 B625149983 B625149984 B625149985 B625149986 B625149988 B625149989 B625149990 B625149991 B625149992 B625149994 B625149996 B625149997 B625149999 B625149976

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

35 other products · FDA event 80895

This product is part of a recall event; the main page for the event is Capnostream20 M Adult ICU (CPM), CS08654RA recalled.

Reported	Class	Recall	Company	Reason	Where
10 Oct 2018	CLASS II	Capnostream20 M Adult ICU (CPM), CS08654RA recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N W/printer - Rohs, Cs08658 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (us) N W/printer recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) N W/Printer Refurbished recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20 (intl) N W/printer recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (INTL) M, CS08654 recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (Intl) N Refurbished, CS78652 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 M NICU (CPM), CS08654RN recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N - Rohs recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20 (intl) N recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) M recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20 (us) N W/printer recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N W/printer - Rohs, Cs051cov recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (Intl) M W/Printer Refurbished, CS78660 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) M W/Printer Refurbished recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 N Cyvital, CS08799 recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US)M Refurbished recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) M TO Masimo recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (Intl) M Refurbished, CS78654 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (Intl) N W/Printer Refurbished, CS78658 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) M W/Printer TO Masimo recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (us) N W/printer - Rohs recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N W/printer - Rohs, Cs08658 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (us) N W/printer - Rohs recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (us) N - Rohs recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) N Refurbished recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 N W/Printer Cyvital, CS08798 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (us) N recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (cov-intl) N W/printer Rohs, Cs051cov recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20p (intl) N - Rohs recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 M W/Printer Cyvital, CS08796 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (Intl) M W/Printer, CS08660 recalled	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream20 (US) M W/Printer recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
10 Oct 2018	CLASS II	Capnostream 20 (us) N recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide

More recalls from Oridion Medical 1987

All 46

Reported	Class	Recall	Company	Reason	Where
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Device Malfunction	Nationwide

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