PlainRecalls
FDA Devices Moderate Class II Ongoing

Flow-e Anesthesia System, model 6887900

Reported: February 14, 2024 Initiated: December 11, 2023 #Z-0991-2024

Product Description

Flow-e Anesthesia System, model 6887900

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.

Details

Recalling Firm
Getinge Usa Sales Inc
Units Affected
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.
Location
Wayne, NJ

Frequently Asked Questions

What product was recalled?
Flow-e Anesthesia System, model 6887900. Recalled by Getinge Usa Sales Inc. Units affected: 86 (US).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-0991-2024.