Flow-e Anesthesia System, model 6887900
FDA Recall #Z-0991-2024 — Class II — December 11, 2023
Product Description
Flow-e Anesthesia System, model 6887900
Reason for Recall
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.
Recalling Firm
Getinge Usa Sales Inc — Wayne, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
86 (US)
Distribution
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.
Code Information
UDI-DI: 07325710010457, serial numbers (US): 50012, 50030, 50031, 50033, 50034, 50035, 50036, 50037, 50038, 50039, 50040, 50041, 50042, 50043, 50046, 50047, 50048, 50051, 50052, 50053, 50054, 50055, 50056, 50057, 50058, 50059, 50060, 50069, 50070, 50071, 50072, 50073, 50074, 50084, 50085, 50086, 50087, 50088, 50089, 50090, 50091, 50092, 50093, 50094, 50096, 50097, 50108, 50109, 50110, 50111, 50132, 50154, 50155, 50193, 50194, 50195, 50196, 50197, 50199, 50211, 50212, 50213, 50214, 50215, 50216, 50217, 50218, 50219, 50220, 50221, 50223, 50224, 50225, 50244, 50245, 50246, 50247, 50248, 50249, 50250, 50251, 50252, 50253, 50254, 50276, 50277.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.