Home / Recalls / Draegar Medical Systems, Inc. / Z-1813-2018

Z-1813-2018 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
May 23, 2018
Initiation Date
March 28, 2018
Termination Date
April 21, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25, 629

Product Description

Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751. Multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals. The lACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The M540 is intended to monitor one patient at a time.

Reason for Recall

Software anomaly resulting in the loss of patient settings and stored patient data.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and to the countries of : Angola, Argentina, Australia Austria Azerbaijan Bahrain Belgium Bolivia Brazil Brunei Dar-es-S Canada Chile China Colombia Costa Rica Czech Republic Denmark Egypt Finland France Germany Ghana Greece Hong Kong Hungary India Indonesia Ireland Italy Japan Jordan Kenya Kuwait Latvia Liechtenstein Lithuania Macedonia Malaysia Maldives Mexico Monaco Mozambique Namibia Netherlands New Zealand Norway Pakistan Panama Peru Poland Portugal Qatar Reunion Russian Fed. Saudi Arabia Singapore Slovenia South Africa South Korea Spain Sweden Switzerland Thailand Trinidad &Tobago Turkey Turkmenistan United Kingdom USA Utd.Arab.Emir. Vietnam

Code Information

Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818 UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751.

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-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-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)