FDA recall Z-0314-2021

GE Healthcare, LLC · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2020-09-17
Report date
2020-11-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukesha, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0314-2021