FDA Enforcement
Class II
Ongoing
Flow-i C40 Anesthesia System, model 6677400
Recall: Z-0989-2024
·
Reported February 14, 2024
Enforcement
- Recall Number
- Z-0989-2024
- Event ID
- 93736
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Getinge Usa Sales Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 14, 2024
- Initiation Date
- December 11, 2023
- Classification Date
- February 6, 2024
- Address
- 1 Geoffrey Way, Wayne, NJ, 07470-2035, United States
Description
Flow-i C40 Anesthesia System, model 6677400
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 Info
UDI-DI: 07325710001318, serial numbers (US): 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446.
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.
Quantity
16 (US)