Flow-i C20 Anesthesia System cybersecurity vulnerability could enable remote attacks
The Flow-i C20 Anesthesia System has a cybersecurity vulnerability allowing potential remote access, denial of service attacks, or code execution. Healthcare facilities should contact the manufacturer for patches and guidance.
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 a Class II FDA medical device recall for a critical-use device (anesthesia system). Although no injuries have been reported and the hazard is theoretical, the potential consequences (denial of service, tampering, remote code execution) create significant risk in a high-stakes clinical setting, meeting the criterion for High severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Getinge Usa Sales Inc is recalling the Flow-i C20 Anesthesia System, model 6677200, due to a cybersecurity vulnerability. Approximately 128 units are affected in the United States.
A potential vulnerability could allow remote access to the anesthesia system through remote login. This vulnerability could enable denial of service attacks, unauthorized tampering, or remote code execution.
These cybersecurity threats could lead to hazardous situations affecting patient safety during anesthesia administration. No injuries or incidents have been reported at this time.
Healthcare facilities should immediately contact Getinge Usa Sales Inc for information about patches, updates, or remediation. Affected devices have UDI-DI 07325710001349 and can be identified by specific serial numbers.
The recalled product
- Product
- Flow-i C20 Anesthesia System, model 6677200
- Manufacturer
- Getinge Usa Sales Inc
- Hazard
- 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 (20)
- UDI-DI: 07325710001349
- Serial Numbers (US): 1202
- 1224
- 1281
- 1282
- 1545
- 1546
- 1651
- 1657
- 1786
- 1787
- 1860
- 1861
- 2023
- 2024
- 2095
- 2186
- 2557
- 2558
- 2559
Distribution
Distributed nationwide across the United States.
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