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

Capnostream 20p (intl) N W/printer - Rohs, Cs08658 recalled

Oridion Medical 1987 is recalling Capnostream 20p (intl) N W/printer - Rohs, Cs08658-03, distributed nationwide in the US. The recall was initiated on 31 Jul 2018 and the FDA has classified it as Class II.

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Lot, batch or date codesPA14170895 PA14170897 PA14170903 PA14170930 PA14170937 PA14170944 PA14170952 PA14170954 PA14170956 PA14170961 PA14170962 PA14170963 PA14170964 PA14170965 PA14170966 PA14170967 PA14170968 PA14170969 PA14170970 PA14170971 PA14170973 PA14170974 PA14170975 PA14170976 PA14170977 PA14170978 PA14170979 PA14170980 PA14170981 PA14170982 PA14170983 PA14170984 PA14170985 PA14170986 PA14170987 PA14170988 PA14170989 PA14170990 PA14170991 PA14170992 PA14170993 PA14170994 PA14170995 PA14170996 PA14170997 PA14170998 PA14170999 PA14171000 PA15171001 PA15171002 PA15171003 PA15171004 PA15171005 PA15171006 PA15171007 PA15171008 PA15171009 PA15171010 PA15171011 PA15171012 PA15171013 PA15171014 PA15171015 PA15171016 PA15171017 PA15171018 PA15171019 PA15171020 PA15171021 PA15171022 PA15171023 PA15171024 PA15171025 PA15171026 PA15171027 PA15171028 PA15171029 PA15171030 PA15171031 PA15171032 PA15171033 PA15171034 PA15171035 PA15171036 PA15171037 PA15171038 PA15171039 PA15171040 PA15171041 PA15171042 PA15171043 PA15171044 PA15171045 PA15171046 PA15171047 PA15171048 PA22172187 PA23172256 PA23172257 PA23172258 PA23172259 PA23172260 PA23172261 PA23172262 PA23172263 PA23172264 PA23172265 PA23172266 PA23172267 PA23172268 PA23172269 PA23172270 PA23172271 PA23172272 PA23172273 PA23172274 PA23172275 PA23172276 PA23172277 PA23172278 PA23172279 PA23172280 PA23172281 PA23172282 PA23172283 PA23172284 PA23172285 PA23172286 PA23172287 PA23172288 PA23172289 PA23172290 PA23172291 PA23172292 PA23172294 PA23172295 PA23172296 PA23172297 PA23172298 PA23172299 PA23172301 PA23172398 PA23172399 PA23172400 PA24172401 PA24172402 PA24172404 PA24172405 PA24172406 PA24172407 PA24172409 PA24172410 PA24172412 PA24172414 PA24172416 PA24172417 PA24172418 PA24172419 PA24172420 PA24172421 PA24172422 PA24172423 PA24172424 PA24172425 PA24172426 PA24172427 PA24172428 PA24172429 PA24172430 PA24172431 PA24172432 PA24172433 PA24172435 PA24172436 PA24172437 PA24172438 PA24172439 PA24172440 PA24172443 PA24172444 PA24172445 PA24172446 PA24172447 PA24172448 PA24172449 PA24172450 PA24172451 PA24172452 PA24172453 PA24172454 PA24172455 PA24172472

Quantity recalled192

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-0043-2019
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 - ROHS, CS08658-03

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?

PA14170895 PA14170897 PA14170903 PA14170930 PA14170937 PA14170944 PA14170952 PA14170954 PA14170956 PA14170961 PA14170962 PA14170963 PA14170964 PA14170965 PA14170966 PA14170967 PA14170968 PA14170969 PA14170970 PA14170971 PA14170973 PA14170974 PA14170975 PA14170976 PA14170977 PA14170978 PA14170979 PA14170980 PA14170981 PA14170982 PA14170983 PA14170984 PA14170985 PA14170986 PA14170987 PA14170988 PA14170989 PA14170990 PA14170991 PA14170992 PA14170993 PA14170994 PA14170995 PA14170996 PA14170997 PA14170998 PA14170999 PA14171000 PA15171001 PA15171002 PA15171003 PA15171004 PA15171005 PA15171006 PA15171007 PA15171008 PA15171009 PA15171010 PA15171011 PA15171012 PA15171013 PA15171014 PA15171015 PA15171016 PA15171017 PA15171018 PA15171019 PA15171020 PA15171021 PA15171022 PA15171023 PA15171024 PA15171025 PA15171026 PA15171027 PA15171028 PA15171029 PA15171030 PA15171031 PA15171032 PA15171033 PA15171034 PA15171035 PA15171036 PA15171037 PA15171038 PA15171039 PA15171040 PA15171041 PA15171042 PA15171043 PA15171044 PA15171045 PA15171046 PA15171047 PA15171048 PA22172187 PA23172256 PA23172257 PA23172258 PA23172259 PA23172260 PA23172261 PA23172262 PA23172263 PA23172264 PA23172265 PA23172266 PA23172267 PA23172268 PA23172269 PA23172270 PA23172271 PA23172272 PA23172273 PA23172274 PA23172275 PA23172276 PA23172277 PA23172278 PA23172279 PA23172280 PA23172281 PA23172282 PA23172283 PA23172284 PA23172285 PA23172286 PA23172287 PA23172288 PA23172289 PA23172290 PA23172291 PA23172292 PA23172294 PA23172295 PA23172296 PA23172297 PA23172298 PA23172299 PA23172301 PA23172398 PA23172399 PA23172400 PA24172401 PA24172402 PA24172404 PA24172405 PA24172406 PA24172407 PA24172409 PA24172410 PA24172412 PA24172414 PA24172416 PA24172417 PA24172418 PA24172419 PA24172420 PA24172421 PA24172422 PA24172423 PA24172424 PA24172425 PA24172426 PA24172427 PA24172428 PA24172429 PA24172430 PA24172431 PA24172432 PA24172433 PA24172435 PA24172436 PA24172437 PA24172438 PA24172439 PA24172440 PA24172443 PA24172444 PA24172445 PA24172446 PA24172447 PA24172448 PA24172449 PA24172450 PA24172451 PA24172452 PA24172453 PA24172454 PA24172455 PA24172472

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 (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	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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All 13,778

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16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide