FDAFDA · Food and drugs·Recall number Z-0990-2024
Flow-c Anesthesia System, model 6887700
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: 07325710009765, serial numbers (US): 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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