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Recall Observatory FDA recall evidence

Device product

Flow-i C40 Anesthesia System, model 6677400

Z-0989-2024

December 11, 2023

Class II

Product summary

Firm
Getinge Usa Sales Inc
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

    reason.device_software_design · v1.0.0

    cybersecurity vulnerability