Home / Recalls / Draegar Medical Systems, Inc. / Z-0258-2020

Z-0258-2020 Class II Ongoing

Recalled by Draegar Medical Systems, Inc. — Andover, MA

Recall Details

Product Type
Devices
Report Date
November 6, 2019
Initiation Date
September 13, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5634

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.

Distribution Pattern

US Nationwide distribution.

Code Information

Software version VG4.1.1/VG4.0.3 and lower

Other recalls by Draegar Medical Systems, Inc.

  • Z-1012-2022 Class II — Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For (March 4, 2022)
  • Z-1104-2021 Class II — Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for (December 23, 2020)
  • Z-0372-2020 Class II — Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, M (October 9, 2019)
  • Z-0974-2019 Class II — Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta (February 8, 2019)
  • Z-0975-2019 Class II — Omega Systems These devices are intended to be used in the environment where (February 8, 2019)
  • Z-1813-2018 Class II — Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, (March 28, 2018)
  • Z-1382-2018 Class II — Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, (February 21, 2018)
  • Z-0942-2018 Class II — INFINITY DUAL HEMO MCable Pod (October 4, 2017)
  • Z-2734-2017 Class II — Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK3 (June 6, 2017)
  • Z-1772-2017 Class II — Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Ox (March 28, 2017)