Company: Draegar Medical Systems, Inc.
Date of Enforcement Report 5/23/2018
Class II:

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. Recall Number: Z-1813-2018

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

RECALLING FIRM/MANUFACTURER
Draegar Medical Systems, Inc., Andover, MA on 3/28/2018 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
25, 629

DISTRIBUTION
Nationwide and Internationally