Home / Recalls / Draegar Medical Systems, Inc. / Z-0974-2019

Z-0974-2019 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
March 13, 2019
Initiation Date
February 8, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10699 in total

Product Description

Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.

Reason for Recall

The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.

Distribution Pattern

US Nationwide distribution including Puerto Rico.

Code Information

All software versions, all serial numbers.

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-0258-2020 Class II — The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone In (September 13, 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)