Recalls / —

—#184237

Product

Flow Sensor Service Part, Catalog 2096513-001-S

FDA product code

BSZ — Gas-Machine, Anesthesia

Device class

Class 2

Medical specialty

Anesthesiology

Affected lot / code info

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)

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

GE will issue an Urgent Medical Device Correction letter to customers with affected flow sensors. This letter will inform the customer of the issue and provide safety instructions, including to inspect all inventory of Flow Sensors. GE Healthcare will replace the Flow Sensors indicated on returned customer response forms, if applicable. In the U.S., this letter will be sent by a traceable means. The letter will be sent to the following titles within the affected accounts: Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. GE Healthcare will document customer acknowledgment of the receipt and understanding of the letter, and the replacement of Flow Sensors, if needed.

Recalling firm

Firm

GE Healthcare, LLC

Address

3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated

2020-09-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #184237. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.