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Draegar Medical Systems, Inc.

Complete recall history across all FDA and CPSC categories — 13 total recalls

Draegar Medical Systems, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (13)

FDA medical device enforcement actions by Draegar Medical Systems, Inc.

Date Product Reason Class
Mar 4, 2022 Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. F... Software issue resulting in temporary loss of central monitoring functionality. Class II
Dec 23, 2020 Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended ... The Infinity M540 patient monitor may randomly reboot due to an error to corr... Class II
Oct 9, 2019 Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower... The devices have potential cybersecurity vulnerabilities, which can include D... Class II
Sep 13, 2019 The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone... Cybersecurity vulnerabilities may cause device to reboot, lose alarm function... Class II
Feb 8, 2019 Omega Systems These devices are intended to be used in the environment whe... The firm is recalling their Delta family of patient monitors software due to ... Class II
Feb 8, 2019 Infinity Delta Family patient monitors The Infinity Delta Series (Delta/De... The firm is recalling their Delta family of patient monitors software due to ... Class II
Mar 28, 2018 Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS2040... Software anomaly resulting in the loss of patient settings and stored patient... Class II
Feb 21, 2018 Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS188... The invasive pressure visual and audible alarms may not activate. Class II
Oct 4, 2017 INFINITY DUAL HEMO MCable Pod Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used wit... Class II
Jun 6, 2017 Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: ... Cockpits with revision index 06 or higher that contain 4GB RAM modules may no... Class II
Mar 28, 2017 Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four... It was reported that a set low O2 alarm does not go off although the measured... Class II
Mar 28, 2017 Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio F... It was reported that a set low O2 alarm does not go off although the measured... Class II
Mar 28, 2017 Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four... It was reported that a set low O2 alarm does not go off although the measured... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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