Product Wiki · Recalls · U.S. FDA — Device Enforcement

Capnostream20 M NICU (CPM), CS08654RN — recall Z-0046-2019

U.S. FDA — Device Enforcement · Israel · 2018-07-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0046-2019
Date of alert
2018-07-31
Country / jurisdiction
Israel
Risk level
Class II
Risk type
recall
Brand
Oridion Medical 1987 Ltd.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
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, Israe
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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