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Recall Observatory FDA recall evidence

Device product

Flow-c Anesthesia System, model 6887700

Z-0990-2024

December 11, 2023

Class II

Product summary

Firm
Getinge Usa Sales Inc
Event
Event 93736
Status
Ongoing
Classification
Class II
Quantity
14 (US)
Official record key
device-enforcement:Z-0990-2024

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: 07325710009765, serial numbers (US): 5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078.

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

    reason.device_software_design · v1.0.0

    cybersecurity vulnerability