CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report
Capnostream20 (US) N W/Printer Refurbished recalled
Oridion Medical 1987 is recalling Capnostream20 (US) N W/Printer Refurbished, 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-0034-2019
- 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) N W/PRINTER REFURBISHED, Part Number CS78657
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?
B200001412 B200001550 B200001579 B200001485 B200002038 B200001062 B200001148 B200001184 B200001273 B200001303 B200001320 B200001332 B200001351 B200001372 B200001384 B200001444 B200001083 B200001394 B200001552 B200001200 B200001233 B200001553 B200001121 B200001123 B200001446 B200001036 B200001124 B200001125 B200001130 B200001035 B200001112 B200001482 B200001095 B400002305 B200001143 B200001252 B400002682 B200001064 B200001435 B200001489 B400002288 B200001136 B200001355 B200001608 B200001998 B200001349 B200001066 B410123252
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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