GE Healthcare, LLC recalls 9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.

Recalled November 11, 2020 · FDA recall Z-0314-2021 · GE Healthcare

Hazard

Flow sensors could have damaged tubes in the form of small punctures or cuts. · FDA Class II

Units

37 devices

Sold at

U.S. states where product was distributed - AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI Foreign countries impacted - Australia, Canada, Czech Republic, Estonia, France, Germany, India, Indonesia, Israel, Italy, Kuwait, Latvia, Macedonia, Madagascar, Malaysia, Nicaragua, Panama, Qatar, Russia, Singapore, Slovenia, Spain, Thailand, Ukraine, United Kingdom

Description

Flow sensors could have damaged tubes in the form of small punctures or cuts.

Product

9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.

Manufacturer(s)

GE Healthcare, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →