FDAFDA · Food and drugs·Recall number Z-0045-2019
Capnostream20 M ADULT ICU (CPM), CS08654RA
Published October 10, 2018 · Recall initiated: July 31, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Oridion Medical 1987 Ltd.
- Distributor
- 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.
- Lot
- B3000011359 B300001366 B300001445 B300001452 B300001460
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
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