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Recall Observatory FDA recall evidence

Device product

Flow Sensor Service Part, Catalog 2096513-001-S

Z-0317-2021

September 17, 2020

Class II

Product summary

Firm
GE Healthcare, LLC
Event
Event 86531
Status
Ongoing
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0317-2021

Official wording

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

Code information: Devices with installed flow sensors with etched manufacturing date of 2020-08 (August 2020). This flow sensor is compatible with the following device models: Aespire 7100/11, Aespire 7900, Aespire View, Aestiva 7100, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, Avance CS2, Amingo (OUS), and 9100c NXT (OUS)

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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