Flow-i C40 Anesthesia System, model 6677400
FDA Recall #Z-0989-2024 — Class II — December 11, 2023
Product Description
Flow-i C40 Anesthesia System, model 6677400
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.
Recalling Firm
Getinge Usa Sales Inc — Wayne, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
16 (US)
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.
Code Information
UDI-DI: 07325710001318, serial numbers (US): 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated