Home / Recalls / Medical Devices
Oridion Medical 1987 Ltd. recalls Capnostream20 N CYVITAL, CS08799
Recalled October 10, 2018 · FDA recall Z-0050-2019 · Oridion Medical 1987
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. · FDA Class II
Units
20
Sold at
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.
Description
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.
Product
Capnostream20 N CYVITAL, CS08799
Manufacturer(s)
Oridion Medical 1987 Ltd.
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →