Z-0989-2024 Class II Ongoing
FDA device recall Z-0989-2024 was initiated by Getinge Usa Sales Inc on December 11, 2023 and is designated Class II. 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 t… The recall status is ongoing. Affected quantity: 16 (US).
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
- 16 (US)
Product Description
Flow-i C40 Anesthesia System, model 6677400
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: 07325710001318, serial numbers (US): 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446.