Class II

Medical Device Recall: Flow-i C40 Anesthesia System, model 6677400

Getinge Usa Sales Inc · December 11, 2023

Reason for Recall

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.

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

16 (US)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0989-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.