GE Healthcare Recalls CARESCAPE Respiratory Modules for Measurement Errors
GE Healthcare is recalling 37 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%) that could impact patient care, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 37 units of the CARESCAPE Respiratory Module E-sCAiOV. 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, Canada, China, Germany, India, Japan, and the United Kingdom. The specific serial numbers and UDI codes for the 37 affected units are listed in the official recall documentation.
Healthcare facilities and users should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, it should be removed from service and returned to GE Healthcare for repair or replacement according to the company's instructions.
The recalled product
- Product
- CARESCAPE Respiratory Module E-sCAiOV
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 37
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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