Flow-i C40 Anesthesia System Recalled for Cybersecurity Vulnerability
Getinge's Flow-i C40 Anesthesia System (model 6677400) contains a potential cybersecurity vulnerability allowing remote login attacks that could result in denial of service, system tampering, or remote code execution.
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 medical device recall for a risk-of-harm product (anesthesia system) where a cybersecurity vulnerability could interfere with critical patient care functions. No injuries, illnesses, or actual incidents have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Getinge Usa Sales Inc is recalling the Flow-i C40 Anesthesia System, model 6677400, due to a potential cybersecurity vulnerability. The vulnerability could allow unauthorized remote access to the system via remote login, potentially leading to denial of service attacks, tampering with system functions, or remote code execution.
Affected anesthesia systems include 16 units distributed across the United States to facilities in Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Indiana, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington, Washington D.C., and West Virginia. The recalled units are identified by specific serial numbers: 5204, 5205, 5206, 5207, 5208, 5209, 5210, 5211, 7185, 7982, 7983, 8426, 8427, 8428, 8445, and 8446.
Healthcare facilities using this anesthesia system should contact Getinge Usa Sales Inc immediately to determine if their system is affected and for guidance on remediation measures.
The recalled product
- Product
- Flow-i C40 Anesthesia System, model 6677400
- 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 (17)
- UDI-DI: 07325710001318
- serial numbers (US): 5204
- 5205
- 5206
- 5207
- 5208
- 5209
- 5210
- 5211
- 7185
- 7982
- 7983
- 8426
- 8427
- 8428
- 8445
- 8446.
Distribution
Distributed nationwide across the United States.
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