Z-0055-2019 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
- 16
Product Description
CAPNOSTREAM 20P (COV-INTL) N W/PRINTER ROHS, CS051COV
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
ME30160001 ME30160002 ME30160003 ME30160004 ME30160005 ME30160006 ME30160007 ME30160008 ME30160009 ME30160010 ME30160011 ME30160012 ME30160013 ME30160014 ME30160015 ME30160016