Home / Recalls / Draegar Medical Systems, Inc. / Z-1382-2018

Z-1382-2018 Class II Terminated

Recalled by Draegar Medical Systems, Inc. — Andover, MA

FDA device recall Z-1382-2018 was initiated by Draegar Medical Systems, Inc. on February 21, 2018 and is designated Class II. Reason for recall: The invasive pressure visual and audible alarms may not activate. The recall status is terminated (terminated April 20, 2020). Affected quantity: 28317 total products.

Recall Details

Product Type: Devices
Report Date: April 25, 2018
Initiation Date: February 21, 2018
Termination Date: April 20, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 28317 total products

Product Description

Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS18841, MS20401, MS20407, 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 professsionals. 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

The invasive pressure visual and audible alarms may not activate.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the following countries:Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Botswana, Brazil, Brunei Dar-es-S, Bulgaria, Canada, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, 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 and Tobago, Turkey, Turkmenistan, United Kingdom, Utd.Arab.Emir. and Vietnam.

Code Information

Catalog Number(s): MS18841, MS20401, MS20407, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, MS31818; UDI Information: 4049098054454, 4049098054447, 4049098054409, 4049098009799, 4049098009751

Other recalls by Draegar Medical Systems, Inc.

Z-1012-2022 Class II — Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For (March 4, 2022)
Z-1104-2021 Class II — Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for (December 23, 2020)
Z-0372-2020 Class II — Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower, M (October 9, 2019)
Z-0258-2020 Class II — The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone In (September 13, 2019)
Z-0974-2019 Class II — Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta (February 8, 2019)
Z-0975-2019 Class II — Omega Systems These devices are intended to be used in the environment where (February 8, 2019)
Z-1813-2018 Class II — Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, (March 28, 2018)
Z-0942-2018 Class II — INFINITY DUAL HEMO MCable Pod (October 4, 2017)
Z-2734-2017 Class II — Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK3 (June 6, 2017)
Z-1772-2017 Class II — Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four Ox (March 28, 2017)