FDAFDA · Food and drugs·Recall number Z-0989-2024
Flow-i C40 Anesthesia System, model 6677400
Published February 14, 2024 · Recall initiated: December 11, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Getinge Usa Sales Inc
- Distributor
- 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.
- Lot
- UDI-DI: 07325710001318, serial numbers (US): 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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