Draegar Medical Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1813-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 28, 2018

Date Posted: May 23, 2018

Recall Number: Z-1813-2018

Event ID: 79871

Reason for Recall:

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

Status: Terminated

Product Quantity: 25, 629

Code Information:

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

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

Voluntary or Mandated:

Voluntary: Firm initiated