Anesthesia System Cybersecurity Vulnerability Poses Denial of Service Risk
The Flow-i C30 Anesthesia System contains a cybersecurity vulnerability allowing remote attackers to cause denial of service, tampering, or code execution, potentially creating hazardous conditions.
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 recall for a cybersecurity vulnerability in a critical-care anesthesia system. While the potential for patient harm is significant—remote code execution or tampering could compromise patient safety during anesthesia delivery—no incidents, injuries, or illnesses have been reported. Per the rubric, risk-of-harm products with no reported injuries score at level 3 (High).
Plain-English summary
The Flow-i C30 Anesthesia System, model 6677300, manufactured by Getinge Usa Sales Inc, has been recalled due to a potential cybersecurity vulnerability. The vulnerability could enable attackers to remotely access the system via remote login and execute denial of service (DoS) attacks, tamper with system operation, or execute arbitrary code, any of which could create hazardous conditions for patients.
The recall affects approximately 4 units in the United States. Affected devices can be identified by serial numbers 1058, 1060, 1167, and 1201.
Healthcare facilities with affected units should immediately contact Getinge Usa Sales Inc to implement any available mitigations or replacement procedures. Physicians and clinical staff should review any guidance provided by the manufacturer regarding the vulnerability and recommended actions.
The recalled product
- Product
- Flow-i C30 Anesthesia System, model 6677300
- 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 (5)
- UDI-DI: 07325710001363
- serial numbers (US): 1058
- 1060
- 1167
- 1201.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27