Recall Z-2734-2017— Draegar Medical Systems, Inc.

Name: FDA recall Z-2734-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-06

Class II · Terminated

Class II FDA medical device recall by Draegar Medical Systems, Inc., initiated 2017-06-06, terminated 2018-06-19. It names one FDA 510(k) clearance: K113798. Product: Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722. Reason: Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station..

Recalling firm: Draegar Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-06
Terminated: 2018-06-19
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K113798 — INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SETDraeger Medical Systems, Inc.·cleared 2012-03-22

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

Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722

Reason for recall

Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio or visual alarms on the Cockpit and Central Station.

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