# FDA recall Z-1813-2018

> **Draegar Medical Systems, Inc.** · Class II · device recall initiated 2018-03-28.

## Product

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

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

## Key facts

- **Recall number:** Z-1813-2018
- **Recalling firm:** Draegar Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-28
- **Report date:** 2018-05-23
- **Termination date:** 2020-04-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1813-2018

## Citation

> AI Analytics. FDA recall Z-1813-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1813-2018. Source: US FDA. Licensed CC0.

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