Z-0258-2020 Class II Ongoing
FDA device recall Z-0258-2020 was initiated by Draegar Medical Systems, Inc. on September 13, 2019 and is designated Class II. Reason for recall: Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network. The recall status is ongoing. Affected quantity: 5634.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- September 13, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5634
Product Description
The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.
Reason for Recall
Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network.
Distribution Pattern
US Nationwide distribution.
Code Information
Software version VG4.1.1/VG4.0.3 and lower