Recall Z-1012-2022— Draegar Medical Systems, Inc.

Name: FDA recall Z-1012-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-04

Class II · Ongoing

Class II FDA medical device recall by Draegar Medical Systems, Inc., initiated 2022-03-04. It names one FDA 510(k) clearance: K130711. Product: Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.. Reason: Software issue resulting in temporary loss of central monitoring functionality..

Recalling firm: Draegar Medical Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-03-04
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

Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.

Reason for recall

Software issue resulting in temporary loss of central monitoring functionality.

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