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.
What this means for you
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
- Hazard
- cybersecurity-vulnerability
- denial-of-service
- remote-code-execution
- tampering
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.
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