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

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

Oridion Medical 1987 is recalling Capnostream 20p (intl) N, 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 codesB642138114 B642138116 B642138122 B643138126 B643138128 B643138132 B643138134 B643138139 B643138144 B643138146 B643138150 B643138153 B643138156 B643138160 B643138166 B643138167 B643138168 B643138169 B643138170 B643138171 B643138172 B643138175 B643138177 B643138179 B643138181 B643138182 B643138190 B643138192 B643138215 B643138216 B643138217 B643138218 B643138219 B643138222 B643138224 B643138225 B643138228 B643138230 B643138232 B643138233 B643138240 B643138241 B643138243 B643138245 B643138253 B644138256 B644138259 B644138286 B644138287 B644138291 B610148829 B610148834 B610148838 B610148845 B611148924 B611148945 B611148946 B611148951 B612149038 B612149039 B615149045 B615149050 B615149054 B615149060 B615149062 B615149063 B615149070 B615149071 B615149073 B615149074 B615149086 B615149088 B615149090 B621149514 B622149593 B622149651 B622149654 B622149655 B622149658 B622149660 B622149663 B622149664 B622149665 B622149666 B622149668 B622149669 B622149670 B622149673 B622149674 B622149675 B622149680 B622149696 B622149701 B622149683 B622149685 B622149695 B622149697 B623149711 B623149712 B623149715 B623149716 B623149719 B624149862 B624149863 B624149866 B624149867 B624149876 B624149877 B624149880 B624149883 B624149887 B624149900 B643138174

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-0037-2019
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, Part Number CS08652-01

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?

B642138114 B642138116 B642138122 B643138126 B643138128 B643138132 B643138134 B643138139 B643138144 B643138146 B643138150 B643138153 B643138156 B643138160 B643138166 B643138167 B643138168 B643138169 B643138170 B643138171 B643138172 B643138175 B643138177 B643138179 B643138181 B643138182 B643138190 B643138192 B643138215 B643138216 B643138217 B643138218 B643138219 B643138222 B643138224 B643138225 B643138228 B643138230 B643138232 B643138233 B643138240 B643138241 B643138243 B643138245 B643138253 B644138256 B644138259 B644138286 B644138287 B644138291 B610148829 B610148834 B610148838 B610148845 B611148924 B611148945 B611148946 B611148951 B612149038 B612149039 B615149045 B615149050 B615149054 B615149060 B615149062 B615149063 B615149070 B615149071 B615149073 B615149074 B615149086 B615149088 B615149090 B621149514 B622149593 B622149651 B622149654 B622149655 B622149658 B622149660 B622149663 B622149664 B622149665 B622149666 B622149668 B622149669 B622149670 B622149673 B622149674 B622149675 B622149680 B622149696 B622149701 B622149683 B622149685 B622149695 B622149697 B623149711 B623149712 B623149715 B623149716 B623149719 B624149862 B624149863 B624149866 B624149867 B624149876 B624149877 B624149880 B624149883 B624149887 B624149900 B643138174

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	Capnostream 20p (intl) N W/printer 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	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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All 13,778

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