Draeger Infinity Acute Care System Recalled for Cybersecurity Vulnerabilities
Draeger Medical Systems is recalling 5,634 Infinity Acute Care System monitors due to cybersecurity vulnerabilities that may cause device reboots and loss of alarm functionality.
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: The recall involves a medical device with a risk of harm (loss of alarm functionality) where no specific injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
Draeger Medical Systems, Inc. is recalling 5,634 units of the Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. The affected models are MS25510, MS25520, and MS26372, specifically those running software version VG4.1.1/VG4.0.3 and lower. The products were distributed nationwide in the United States.
The recall is being issued because cybersecurity vulnerabilities may cause the device to reboot, lose alarm functionality, and/or lose communication with the cockpit and/or the Infinity Network. These technical failures could compromise the monitoring capabilities of the patient monitor.
Healthcare facilities and users of these devices should contact Draeger Medical Systems for instructions on how to address the cybersecurity vulnerabilities and ensure the safety of patient monitoring.
The recalled product
- Product
- The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
- Manufacturer
- Draegar Medical Systems, Inc.
- Category
- Medical Device — Patient Monitor
- Affected units
- 5,634
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 (1)
- Software version VG4.1.1/VG4.0.3 and lower
Distribution
Distributed nationwide across the United States.
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