Z-0372-2020 Class II Ongoing
FDA device recall Z-0372-2020 was initiated by Draegar Medical Systems, Inc. on October 9, 2019 and is designated Class II. Reason for recall: The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering. The recall status is ongoing. Affected quantity: 12204.
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2019
- Initiation Date
- October 9, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12204
Product Description
Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301
Reason for Recall
The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering.
Distribution Pattern
US nationwide distribution.
Code Information
All systems using Software version VG2.3.1 and lower