Home / Recalls / Draeger Medical Systems, Inc. / Z-1471-2023

Z-1471-2023 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
May 3, 2023
Initiation Date
April 5, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6803 systems

Product Description

Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower

Reason for Recall

The software on the Infinity CentralStation drops peaks on narrow waveforms causing the Infinity M300 to fail to meet Frequency and Impulse Response requirements. In this condition, ECG waveforms with unusually narrow and/or high frequency QRS may be displayed or printed with QRS amplitudes intermittently lower than actual.

Distribution Pattern

Worldwide - US Nationwide distribution.

Code Information

UDI-DI: 04049098001878; All Systems Running Software versions: ICS VG2.1.3 and lower

Other recalls by Draeger Medical Systems, Inc.

  • Z-1066-2025 Class II — Infinity Central Station. Model Number: MS26800 The Infinity CentralStation ( (January 14, 2025)
  • Z-2189-2024 Class II — Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, M (May 13, 2024)
  • Z-1992-2023 Class II — Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): R (May 16, 2023)
  • Z-1472-2023 Class II — Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse o (April 5, 2023)
  • Z-1365-2022 Class II — Draeger Globe-Trotter and Globe-Trotter IC, Model numbers MS20508 and MS20509. n (May 20, 2022)
  • Z-2047-2018 Class I — Draeger Jaundice Meter JM-105 The device is intended for use in hospitals, cl (May 15, 2018)
  • Z-2046-2018 Class I — Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, c (May 15, 2018)
  • Z-1440-2014 Class I — Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part n (March 5, 2014)
  • Z-1298-2014 Class I — Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (E (February 7, 2014)
  • Z-0714-2014 Class II — Draeger Infinity Acute Care System Monitoring Solution (December 10, 2013)