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All product recalls associated with Draegar Medical Systems, Inc..
Total Recalls
4
Past Year
0
Class I (Serious)
0
Most Recent
Mar 2022
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Software issue resulting in temporary loss of central monitoring functionality.
The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and read the header data of files in the memory of the device. Under this situation, the device will try to reboot to mitigate the error. The device will be available again for use within 30 seconds. If this error continues and the M540 reboots three times in a time span of 10 minutes, it will enter a fail-state. A fail-state will annunciate itself with a continuous sound to alert the user. The M540 will reset to factory default and the user can manually configure and readmit the patient to continue patient monitoring.
The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.