Recall Z-0754-2020 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
GE Healthcare, LLC
CARESCAPE Respiratory Module E-sCO
| Date | Jan 10, 2020 (initiated Sep 27, 2019) |
| Status | Terminated |
| Reason | 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 | Process control |
| Action | 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) Configu |
| Quantity | 167 units |
| Distribution | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123195 | CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES GE Healthcare Finland Oy, Feb 28, 2013 |
| K150245 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX GE Healthcare Finland Oy, Jul 17, 2015 |
| K171028 | CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories GE Healthcare Finland Oy, Aug 17, 2017 |
| K183394 | CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO GE Healthcare Finland Oy, May 1, 2019 |