Home / Recalls / Draegar Medical Systems, Inc. / Z-0372-2020

Z-0372-2020 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
November 20, 2019
Initiation Date
October 9, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12204

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.

Distribution Pattern

US nationwide distribution.

Code Information

All systems using Software version VG2.3.1 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-0258-2020 Class II — The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone In (September 13, 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)