The Recall Desk
HighFDA (Devices)·Z-0314-2021·Announced 2020-11-11

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.

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 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
Category
Medical Device — Imaging Equipment
Hazard
Affected units
37

Distribution

Distributed in 36 states:

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.

See all 7 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · tube damage

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