CARESCAPE Respiratory Module E-sCOVX
FDA device recall Z-0755-2020 · posted 2020-01-10 · Terminated
Recall details
- Recalling firm
- GE Healthcare, LLC
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 3 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 (R
- Date initiated
- 2019-09-27
- Date posted
- 2020-01-10
- Date terminated
- 2023-09-26
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO (K183394) | GE Healthcare Finland Oy | 2019-05-01 |
| CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories (K171028) | GE Healthcare Finland Oy | 2017-08-17 |
| CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX (K150245) | GE Healthcare Finland Oy | 2015-07-17 |