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

Capnostream20 (US) M TO Masimo recalled by Oridion Medical 1987

Oridion Medical 1987 is recalling Capnostream20 (US) M TO Masimo, 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 codesB500002658

Quantity recalled1

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-0030-2019
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

Capnostream20 (US) M TO MASIMO, Part Number CS08750

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

Is Capnostream20 (US) M TO Masimo recalled?

Yes. Oridion Medical 1987 recalled Capnostream20 (US) M TO Masimo on 31 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-0030-2019.

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?

B500002658

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

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	Lead & Heavy Metals	Nationwide
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Lead & Heavy Metals	Nationwide
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Lead & Heavy Metals	Nationwide
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Lead & Heavy Metals	Nationwide
26 Mar 2025Device	CLASS II	Microstream Instructions for Use recalled by Oridion Medical 1987	Oridion Medical 1987	Lead & Heavy Metals	Nationwide

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