Getinge Usa Sales Inc: Medical Device Recall in 2024 - (Recall #: Z-0989-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Flow-i C40 Anesthesia System, model 6677400

Product Classification:

Class II

Date Initiated: December 11, 2023

Date Posted: February 14, 2024

Recall Number: Z-0989-2024

Event ID: 93736

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.

Status: Ongoing

Product Quantity: 16 (US)

Code Information:

UDI-DI: 07325710001318, serial numbers (US): 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, 8446.

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.

Voluntary or Mandated:

Voluntary: Firm initiated