Agency classClass IIOur severity:High FDA (Devices)·Z-0991-2024·Announced 2024-02-14

Flow-e Anesthesia System Model 6887900 Cybersecurity Vulnerability Recall

The Flow-e Anesthesia System model 6887900 is recalled due to a cybersecurity vulnerability that could allow remote access, denial of service, or code execution, potentially affecting anesthesia delivery safety.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for a cybersecurity vulnerability that could enable denial of service, remote code execution, or system tampering. The source indicates these issues could lead to a hazardous situation. With no reported incidents or injuries, this fits the High category for risk-of-harm medical devices.

Plain-English summary

The Flow-e Anesthesia System, model 6887900, manufactured by Getinge Usa Sales Inc, is being recalled by the FDA due to a cybersecurity vulnerability that could potentially be exploited via remote login.

The vulnerability could enable denial of service (DoS) attacks, unauthorized tampering, or remote code execution on the system. Any of these could lead to a hazardous situation during anesthesia delivery.

The recall affects 86 units distributed nationwide across multiple states including Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington, West Virginia, and the District of Columbia.

Healthcare facilities using the affected units should contact Getinge Usa Sales Inc or the FDA for guidance on system remediation or replacement options.

The recalled product

Product: Flow-e Anesthesia System, model 6887900
Manufacturer: Getinge Usa Sales Inc
Category: Medical Device — Anesthesia System
Hazard: cybersecurity-vulnerability
denial-of-service
remote-code-execution
tampering
Affected units: 86

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI-DI: 07325710010457
serial numbers (US): 50012
50030
50031
50033
50034
50035
50036
50037
50038
50039
50040
50041
50042
50043
50046
50047
50048
50051
50052

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Getinge Usa Sales Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Getinge Usa Sales Inc

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