Recall Z-0990-2024— Getinge Usa Sales Inc

Name: FDA recall Z-0990-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-11

Class II · Ongoing

Class II FDA medical device recall by Getinge Usa Sales Inc, initiated 2023-12-11. It names one FDA 510(k) clearance: K133958. Product: Flow-c Anesthesia System, model 6887700. 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..

Recalling firm: Getinge Usa Sales Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-12-11
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K133958 — FLOW-I ANESTHESIA SYSTEM C20, C30 & C40Maquet Critical Care AB·cleared 2014-03-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Flow-c Anesthesia System, model 6887700

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.