Draeger Infinity M300 Telemetry Devices Recalled for Cybersecurity Vulnerabilities
Draeger Medical Systems is recalling Infinity M300 telemetry monitoring devices due to cybersecurity vulnerabilities including DDoS, Spoofing, and Tampering.
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 cybersecurity vulnerabilities (risk-of-harm products) where no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Draeger Medical Systems, Inc. is recalling the Infinity M300 telemetry monitoring device. The recall affects 12,204 units with software versions VG2.3.1 and lower, including model numbers MS25755, MS26076, MS26031, MS18623, MS22862, and MS25301. These devices were distributed nationwide in the United States.
The recall is being conducted because the devices have potential cybersecurity vulnerabilities. These vulnerabilities can include Distributed Denial of Service (DDoS), Spoofing, and Tampering. The source text does not report any specific injuries, illnesses, or deaths associated with these vulnerabilities.
Healthcare facilities and users should contact Draeger Medical Systems for instructions on how to address these cybersecurity risks. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
- Manufacturer
- Draegar Medical Systems, Inc.
- Affected units
- 12,204
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)
- All systems using Software version VG2.3.1 and lower
Distribution
Distributed nationwide across the United States.
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