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

FDA Device Recall #Z-1382-2018 — Class II — February 21, 2018

Recall Summary

Recall Number Z-1382-2018
Classification Class II — Moderate risk
Date Initiated February 21, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Draegar Medical Systems, Inc.
Location Andover, MA
Product Type Devices
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.

Lot / 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 from Draegar Medical Systems, Inc.

Recall # Classification Product Date
Z-1012-2022 Class II Drager Infinity CentralStation Software version... Mar 4, 2022
Z-1104-2021 Class II Infinity Acute Care System (IACS) Monitoring So... Dec 23, 2020
Z-0372-2020 Class II Infinity M300 telemetry monitoring device Softw... Oct 9, 2019
Z-0258-2020 Class II The Infinity Acute Care System (IACS) Monitorin... Sep 13, 2019
Z-0975-2019 Class II Omega Systems These devices are intended to ... Feb 8, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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