GE Healthcare Recalls 9100c NXT Systems Due to Flow Sensor Defects
GE Healthcare is recalling 37 9100c NXT systems because flow sensors may have damaged tubes with small punctures or cuts.
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. The hazard involves potential tube damage (punctures or cuts) which poses a risk of harm, but the source text does not report any specific injuries, illnesses, or fatalities, placing it in the 'High' category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 37 units of the 9100c NXT system. The recall is due to a defect where flow sensors could have damaged tubes in the form of small punctures or cuts.
The affected devices are those with installed flow sensors that have an etched manufacturing date of August 2020 (2020-08). The product is licensed and distributed outside of the US only, though the distribution pattern lists various U.S. states and foreign countries impacted.
This recall is classified as Class II by the FDA. Users should contact GE Healthcare for further instructions regarding the affected devices.
The recalled product
- Product
- 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 37
Distribution
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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