Z-0050-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- July 31, 2018
- Termination Date
- September 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
Capnostream20 N CYVITAL, CS08799
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.
Distribution Pattern
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.
Code Information
B400002614 B400002628 B400002640 B400002642 B400002645 B400002646 B400002653 B400002658 B400002659 B400002660 B400002750 B400002760 B417135110 B417135186 B417135189 B418135223 B418135272 B418135278 B419135324 B419135329