Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless telemetry devices.
FDA Recall Z-1012-2022 · Posted None
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Recalling FirmDraegar Medical Systems, Inc.
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2022-03-04
Product Quantity1950 (1574 OUS + 376 US)
Reason for Recall
Software issue resulting in temporary loss of central monitoring functionality.
Firm Action
A notification signed 03/08/2022, issued via certified mail on 03/11/2022 and 03/24/2022, notified customers of the impacted software versions, that a software update will be deployed to correct the issue, and provided interim instructions regarding use of USB devices. Customers are to notify all users and return the acknowledgement form. For questions please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).
Root Cause
Software design
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IA, ID, IL, IN, LA, MN, MS, NC, NE, NH, NY, OH, PA, SD, TN, TX, WA, WI, and 58 additional foreign countries.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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