RecallRadar

FDA Device recall Z-0989-2024

Flow-i C40 Anesthesia System, model 6677400

On 2024-02-14 the FDA classified a Class II recall of Flow-i C40 Anesthesia System, model 6677400 by Getinge Usa Sales, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0989-2024
ClassificationClass II
Statusongoing
Initiated2023-12-11
Published2024-02-14
Last updated2026-09-13 11:57 UTC
CompanyGetinge Usa Sales
DistributionUS

Product

Flow-i C40 Anesthesia System, model 6677400

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.

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0989-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.