Recall Z-0258-2020— Draegar Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Draegar Medical Systems, Inc., initiated 2019-09-13. It names 2 FDA 510(k) clearances: K113798, K093788. Product: The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone Infinity M540 patient monitor. Model nos. MS25510, MS25520, MS26372.. Reason: Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose communication with cockpit and/or the Infinity Network..
- Recalling firm
- Draegar Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-09-13
- Firm location
- Andover, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K113798 — INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
- K093788 — INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.