9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Recall
- Recall Number
- Z-0314-2021
- Event Number
- 86531
- Firm
- GE Healthcare, LLC
- FEI Number
- 2126677
- Product Code
- BSZ
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- September 17, 2020
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Flow sensors could have damaged tubes in the form of small punctures or cuts.
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.
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
37 devices