Device product
Flow-i C40 Anesthesia System, model 6677400
Z-0989-2024
Product summary
- Event
- Event 93736
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16 (US)
- Official record key
device-enforcement:Z-0989-2024
Official wording
Reason: 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.
Code information: UDI-DI: 07325710001318, serial numbers (US): 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446.
Distribution pattern: 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.
Derived failure modes
-
Device software or design
cybersecurity vulnerability