GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Measurement Errors
GE Healthcare is recalling 167 CARESCAPE Respiratory Module E-sCO units because displayed oxygen values may be incorrect, potentially 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, but the source text does not report any specific injuries, illnesses, or fatalities, 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 167 units of the CARESCAPE Respiratory Module E-sCO. 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 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.
Healthcare facilities and users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a unit is affected, users should follow the instructions provided by GE Healthcare for remediation or replacement.
The recalled product
- Product
- CARESCAPE Respiratory Module E-sCO
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 167
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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