GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Measurement Errors
GE Healthcare is recalling 59 CARESCAPE Respiratory Modules 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%) in critical respiratory parameters, which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling 59 units of the CARESCAPE Respiratory Module E-sCAiOE. 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 these specific oxygen 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.
Healthcare facilities and users should identify affected units by checking the specific manufacturing lot or serial numbers listed in the official recall documentation. Users should contact GE Healthcare for instructions on how to proceed with the recall.
The recalled product
- Product
- CARESCAPE Respiratory Module E-sCAiOE
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 59
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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