GE Healthcare, LLC: Medical Device Recall in 2020 - (Recall #: Z-0755-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

CARESCAPE Respiratory Module E-sCOVX

Product Classification:

Class I

Date Initiated: September 27, 2019

Date Posted: January 22, 2020

Recall Number: Z-0755-2020

Event ID: 84034

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.

Status: Terminated

Product Quantity: 3 units

Code Information:

Mfg. Lot or Serial # UDI # SGV19276034HA 010084068210428921SGV19276034HA11190702 SGV19266019HA 010084068210428921SGV19266019HA11190626 SGV14404046HA Not Applicable

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

Voluntary or Mandated:

Voluntary: Firm initiated