GE Healthcare Recalls CARESCAPE Respiratory Modules Due to O2 Sensor Failure
GE Healthcare is recalling 748 CARESCAPE respiratory modules and Airway Gas Options due to a potential O2 sensor component failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a potential failure of a critical O2 sensor in a life-support medical device. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
GE Healthcare, LLC is recalling 748 units of CARESCAPE Respiratory Modules (E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE) and the Airway Gas Option N-CAiO, along with their respective service exchange units. The recall affects 307 units in the United States and 441 units outside the US.
The recall was initiated because GE Healthcare became aware of a potential safety issue caused by a failure of an O2 sensor component. The affected modules may be in use with various GE host devices, including CARESCAPE Monitors B850, B650, and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, and B40 Patient Monitors.
The affected units were distributed across 18 US states and 37 countries outside the US. The source text does not specify the corrective action consumers or healthcare facilities should take, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units. The affected modules could be in use with any of the following GE host devices: -CARESCAPE respiratory modules with…
- Manufacturer
- GE Healthcare, LLC
Distribution
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