Recall Z-0991-2024 ยท BSZ Gas-Machine, Anesthesia
Getinge Usa Sales Inc
Flow-e Anesthesia System, model 6887900
| Date | Feb 6, 2024 (initiated Dec 11, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | An Urgent Medical Device Correction notice dated December 21, 2023 was issued via FedEx. The letter advises customers to examine inventory immediately to determine if you have any affected product. Directions are outlined for 1) Users with system version 4.8 and above with a Flow Anesthesia System connected to Connected Services directly via the Ethernet port on the Flow Anesthesia System (i.e., without a Getinge Connect module) and for 2) Users with system version 4.7 and below with Flow Anesthesia System connected to Remote Services via ethernet cable. Customers are asked to complete and re |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133958 | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 Maquet Critical Care AB, Mar 20, 2014 |