Z-0760-2020 Class I Terminated
FDA device recall Z-0760-2020 was initiated by GE Healthcare, LLC on September 27, 2019 and is designated Class I. 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. The recall status is terminated (terminated September 26, 2023). Affected quantity: 12 units.
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
- 12 units
Product Description
Reason for Recall
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