—#177042

Product

CARESCAPE Respiratory Module E-sCAiOVE

FDA product code: CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

The firm issued the Urgent Medical Device Correction Letter dated 09/27/2019. The letter describes the failure and requests replacement of the affected module with another module. If a replacement is not available, the consignee is directed to follow the instructions below to ensure that your respiratory module O2 reading is within specifications (a) before any new patient case is started and (b) for prolonged patient cases, at a minimum of once a day: 1) Connect the module to the host device; 2) Ensure the module is fully warmed up by having it powered on for minimum 20 minutes; 3) Configure the O2 reading and waveform to the host device screen as defined in the host device instructions; 4) Feed 100% O2 gas flow from the ventilator to the module and observe the O2 reading and waveform; and 5) Ensure the O2 reading is within specifications 100% +/-3% and there is no erratic behavior in the waveform. 6) If you are unable to complete the above steps successfully, remove the respiratory module from clinical use and quarantine. Contact GE Healthcare Service or your local Service Representative. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated: 2019-09-27
Posted by FDA: 2020-01-10
Terminated: 2023-09-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #177042. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.