Flow-c Anesthesia System cybersecurity vulnerability in 14 units
The Flow-c Anesthesia System model 6887700 has a cybersecurity vulnerability allowing potential denial of service, tampering, or remote code execution via remote login. Fourteen units were distributed in the United States.
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: This is an FDA Class II cybersecurity vulnerability affecting a critical medical device. While no incidents have been reported, the potential for denial of service, unauthorized tampering, or remote code execution could lead to patient harm. The hazard is theoretical but carries significant risk.
Plain-English summary
The Flow-c Anesthesia System, model 6887700, manufactured by Getinge Usa Sales Inc, is being recalled due to a cybersecurity vulnerability.
The vulnerability could be exploited through remote login access to the system. This could result in a denial of service attack, unauthorized tampering with system operations, or remote code execution. Any of these outcomes could lead to a hazardous situation affecting patient care or clinical operations.
Fourteen units of this system were distributed in the United States across Alabama, Arizona, Arkansas, California, Colorado, the District of Columbia, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington, and West Virginia. The FDA classified this as a Class II recall.
If you operate or maintain a Flow-c Anesthesia System with one of the affected serial numbers (5024, 5025, 5026, 5027, 5028, 5043, 5044, 5045, 5046, 5047, 5048, 5049, 5050, 5078), contact Getinge Usa Sales Inc for remediation instructions. The manufacturer should be consulted before continued use of any affected unit.
The recalled product
- Product
- Flow-c Anesthesia System, model 6887700
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- cybersecurity-vulnerability
- denial-of-service
- tampering
- remote-code-execution
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 (15)
- UDI-DI: 07325710009765
- serial numbers (US): 5024
- 5025
- 5026
- 5027
- 5028
- 5043
- 5044
- 5045
- 5046
- 5047
- 5048
- 5049
- 5050
- 5078.
Distribution
Distributed nationwide across the United States.
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