—#177039

Product

CARESCAPE Respiratory Module E-sCAiOV

FDA product code: CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K123195, K150245, K171028, K183394
Affected lot / code info: Mfg. Lot or Serial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ot 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 #177039. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.