CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report
Capnostream 20p (intl) N W/printer - Rohs, Cs051cov recalled
Oridion Medical 1987 is recalling Capnostream 20p (intl) N W/printer - Rohs, Cs051cov-03, 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
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-0056-2019
- 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, CS051COV-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.
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?
PM31170001 PM31170002 PM31170003 PM31170004 PM31170005 PM31170006 PM31170007 PM31170008 PM37170009 PM37170010 PM37170011 PM37170012 PM37170013 PM37170014 PM37170015 PM37170016 PM37170017 PM37170018 PM37170019 PM37170020 PM37170021 PM37170022 PM37170023 PM37170024 PM37170025 PM37170026 PM37170027 PM37170028 PM37170029 PM37170030 PM37170031 PM37170032 PM37170033 PM37170034 PM37170035 PM37170036 PM37170037 PM37170038 PM37170039 PM37170040 PM37170041 PM37170042 PM37170043 PM37170044 PM37170045 PM37170046 PM37170047 PM37170048 PM37170049 PM37170050 PM37170051 PM37170052 PM37170053 PM37170054 PM37170055 PM37170056
Where was it sold?
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.
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 80895This product is part of a recall event; the main page for the event is Capnostream20 M Adult ICU (CPM), CS08654RA recalled.
More recalls from Oridion Medical 1987
All 46| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Microstream Instructions for Use recalled by Oridion Medical 1987 | Oridion Medical 1987 | Device Malfunction | Nationwide |
| Device | CLASS II | Microstream Instructions for Use recalled by Oridion Medical 1987 | Oridion Medical 1987 | Device Malfunction | Nationwide |
| Device | CLASS II | Microstream Instructions for Use recalled by Oridion Medical 1987 | Oridion Medical 1987 | Device Malfunction | Nationwide |
| Device | CLASS II | Microstream Instructions for Use recalled by Oridion Medical 1987 | Oridion Medical 1987 | Device Malfunction | Nationwide |
| Device | CLASS II | Microstream Instructions for Use recalled by Oridion Medical 1987 | Oridion Medical 1987 | Device Malfunction | Nationwide |
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