medical Class II Updated 2018-05-23

Draegar Medical Systems, Inc. recalls Infinity Acute Care System (lACS) Monitoring Solution; Catal

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818 UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751.
View official government recall

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