Recall Z-1813-2018— Draegar Medical Systems, Inc.

Name: FDA recall Z-1813-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-28

Class II · Terminated

Class II FDA medical device recall by Draegar Medical Systems, Inc., initiated 2018-03-28, terminated 2020-04-21. It names one FDA 510(k) clearance: K113798. 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: Software anomaly resulting in the loss of patient settings and stored patient data..

Recalling firm: Draegar Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-28
Terminated: 2020-04-21
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K113798 — INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SETDraeger Medical Systems, Inc.·cleared 2012-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.