GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Measurement Errors
GE Healthcare is recalling 14 CARESCAPE Respiratory Module E-sCAiOVE units because displayed oxygen values may be incorrect, causing up to 50% measurement error.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a significant measurement error (up to 50%) that could impact patient care, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 14 units of the CARESCAPE Respiratory Module E-sCAiOVE. The recall was initiated because the displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect. This defect could result in up to 50% measurement error in the EtO2/FiO2 values.
The affected units were distributed in the United States and in numerous countries outside the US, including 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 the United Kingdom. Specific lot and serial numbers for the affected units are listed in the agency's recall record.
Healthcare facilities should identify the affected units by checking the serial numbers against the recall list. Users should contact GE Healthcare for instructions on how to proceed with the recall.
The recalled product
- Product
- CARESCAPE Respiratory Module E-sCAiOVE
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 14
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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