Z-0988-2024 Class II Ongoing

Recalled by Getinge Usa Sales Inc — Wayne, NJ

Recall Details

Product Type
Devices
Report Date
February 14, 2024
Initiation Date
December 11, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 (US)

Product Description

Flow-i C30 Anesthesia System, model 6677300

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.

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.

Code Information

UDI-DI: 07325710001363, serial numbers (US): 1058, 1060, 1167, 1201.