Recall Z-0372-2020— Draegar Medical Systems, Inc.

Name: FDA recall Z-0372-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-09

Class II · Ongoing

Class II FDA medical device recall by Draegar Medical Systems, Inc., initiated 2019-10-09. It names one FDA 510(k) clearance: K130711. Product: Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, Model Numbers MS25755, MS26076, MS26031, MS18623, MS22862, MS25301. Reason: The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of Service (DDoS), Spoofing, and Tampering..

Recalling firm: Draegar Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2019-10-09
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K130711 — INFINITY CENTRALSTATION WITH INFINITY M300Draeger Medical Systems, Inc.·cleared 2013-04-11

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.