GE Healthcare, LLC: Medical Device Recall in 2020 - (Recall #: Z-0759-2020)

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-sCAiOVE

Product Classification:

Class I

Date Initiated: September 27, 2019

Date Posted: January 22, 2020

Recall Number: Z-0759-2020

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: 14 unit

Code Information:

Mfg. Lot or Serial # SGV19295006HA 010084068210430221SGV19295006HA11190717 SGV19255001HA 010084068210430221SGV19255001HA11190618 SGV19295019HA 010084068210430221SGV19295019HA11190717 SGV19255002HA 010084068210430221SGV19255002HA11190618 SGV19255004HA 010084068210430221SGV19255004HA11190618 SGV19255010HA 010084068210430221SGV19255010HA11190618 SGV19255017HA 010084068210430221SGV19255017HA11190618 SGV19255019HA 010084068210430221SGV19255019HA11190618 SGV16385015HA 010084068210430221SGV16385015HA11160919 SGV15285005HA Not Applicable SGV19285017HA 010084068210430221SGV19285017HA11190710 SGV19285019HA 010084068210430221SGV19285019HA11190710 SGV19285007HA 010084068210430221SGV19285007HA11190710 SGV19259708HA 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