FDA-Device2018-10-10Class II
Capnostream20 (US) M TO MASIMO, Part Number CS08750
Oridion Medical 1987 Ltd.
Hazard
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.
Sold states
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.
Affected count
1
Manufactured in
Har Hotzvim Industrial Park Box 45025, Har Hotzvim Industrial Park, Jerusalem, Israel
Products
Capnostream20 (US) M TO MASIMO, Part Number CS08750
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0030-2019Don't want to check this manually?
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