Z-0755-2020 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2020
- Initiation Date
- September 27, 2019
- Termination Date
- September 26, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
CARESCAPE Respiratory Module E-sCOVX
Reason for Recall
Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
Distribution Pattern
US OUS: Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Korea (Republic of), Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Peru, Poland, Republic of Serbia, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, and Unites Kingdom
Code Information
Mfg. Lot or Serial # UDI # SGV19276034HA 010084068210428921SGV19276034HA11190702 SGV19266019HA 010084068210428921SGV19266019HA11190626 SGV14404046HA Not Applicable