FDA-Device2024-02-14Class II

Flow-i C40 Anesthesia System, model 6677400

Getinge Usa Sales Inc
Hazard

Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia System, any of which could lead to a hazardous situation.

Sold states
Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IN, MA, MI, MO, NY, OH, OR, PA, TX, VA, WA & WV.
Affected count
16 (US)
Manufactured in
1 Geoffrey Way, Wayne, NJ, United States
Products
Flow-i C40 Anesthesia System, model 6677400

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0989-2024

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