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

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

Oridion Medical 1987 is recalling Capnostream 20 (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 codesB200001028 B200001034 B200001060 B200001022 B200001023 B200001038 B200001041 B200001042 B200001052 B200001054 B200001055 B200001056 B200001024 B200001039 B200001040 B200001049 B200001051 B200001058 B200001059 B200001026 B200001029 B200001037 B200001031 B200001094 B200001033 B200001172 B200001228 B200001050 B200001459 B200001025 B400002243 B200001045 B200001047 B200001044 B200001138 B200001689 B200001832 B200001837 B200001854 B200001855 B200001645 B200001633 B200001917 B400002296 B400002401 B400002435 B400002444 B400002350 B400002453 B400002451 B400002454 B200001839 B200001573 B440112951 B440112966 B440112973 B417123382 B417123383 B417123387 B440112949 B417123381 B417123384 B417123386 B417123385 B410123238 B447123766 B447123768 B447123769 B448123792 B200002165 B411134508 B411134523 B411134459 B411134469 B440112945 B400002441 B416135016 B416135070 B400002237 B423135806 B423135807 B423135808 B423135811 B424135818 B424135821 B424135824 B424135828 B424135830 B424135832 B424135833 B424135835 B424135836 B424135839 B424135842 B424135843 B424135846 B424135848 B424135853 B424135856 B424135859 B424135861 B200001159 B428136417 B428136419 B428136423 B428136425 B428136427 B428136428 B428136431 B428136432 B428136438 B428136444 B428136445 B428136447 B428136455 B428136459 B428136462 B428136464 B428136466 B428136407 B428136408 B428136414 B428136418 B428136421 B428136422 B428136424 B428136426 B428136429 B428136434 B428136436 B428136441 B428136443 B428136446 B428136449 B428136450 B428136452 B428136456 B428136457 B428136458 B428136461 B428136463 B200001053 B407123203 B428136416

Quantity recalled144

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-0040-2019
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 20 (INTL) N W/PRINTER, Part Number CS08658

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?

B200001028 B200001034 B200001060 B200001022 B200001023 B200001038 B200001041 B200001042 B200001052 B200001054 B200001055 B200001056 B200001024 B200001039 B200001040 B200001049 B200001051 B200001058 B200001059 B200001026 B200001029 B200001037 B200001031 B200001094 B200001033 B200001172 B200001228 B200001050 B200001459 B200001025 B400002243 B200001045 B200001047 B200001044 B200001138 B200001689 B200001832 B200001837 B200001854 B200001855 B200001645 B200001633 B200001917 B400002296 B400002401 B400002435 B400002444 B400002350 B400002453 B400002451 B400002454 B200001839 B200001573 B440112951 B440112966 B440112973 B417123382 B417123383 B417123387 B440112949 B417123381 B417123384 B417123386 B417123385 B410123238 B447123766 B447123768 B447123769 B448123792 B200002165 B411134508 B411134523 B411134459 B411134469 B440112945 B400002441 B416135016 B416135070 B400002237 B423135806 B423135807 B423135808 B423135811 B424135818 B424135821 B424135824 B424135828 B424135830 B424135832 B424135833 B424135835 B424135836 B424135839 B424135842 B424135843 B424135846 B424135848 B424135853 B424135856 B424135859 B424135861 B200001159 B428136417 B428136419 B428136423 B428136425 B428136427 B428136428 B428136431 B428136432 B428136438 B428136444 B428136445 B428136447 B428136455 B428136459 B428136462 B428136464 B428136466 B428136407 B428136408 B428136414 B428136418 B428136421 B428136422 B428136424 B428136426 B428136429 B428136434 B428136436 B428136441 B428136443 B428136446 B428136449 B428136450 B428136452 B428136456 B428136457 B428136458 B428136461 B428136463 B200001053 B407123203 B428136416

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	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	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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