Draeger Infinity Acute Care System Recalled for Software Anomaly
Draeger Medical Systems is recalling the Infinity Acute Care System due to a software anomaly that can cause loss of patient settings and stored data.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is FDA Class II, which typically corresponds to a High severity score when there is a risk of harm but no reported illnesses or injuries. The software anomaly poses a risk to patient care by losing critical data, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Draeger Medical Systems, Inc. is voluntarily recalling the Infinity Acute Care System (lACS) Monitoring Solution. The affected units include catalog numbers MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS26372, and MS31818, along with associated UDI information. A total of 25,629 units are involved in this recall.
The reason for the recall is a software anomaly within the system. This defect can result in the loss of patient settings and stored patient data. The Infinity Acute Care System is designed for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where care is provided by trained healthcare professionals.
The recalled products have been distributed worldwide, including nationwide distribution within the USA and to numerous other countries such as Canada, Australia, Germany, Japan, and the United Kingdom. Healthcare providers using these systems should be aware of this potential data loss issue.
The recalled product
- 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
- Manufacturer
- Draegar Medical Systems, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Catalog Numbers:MS20401
- MS20724
- MS22956
- MS25510
- MS25520
- MS25643
- MS26196
- MS26372
- MS31818 UDI Information: 4049098054454
- 4049098054447
- 4049098054409
- 4049098009799
- 4049098009751.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Draegar Medical Systems, Inc.
See all →- HighDrager Infinity CentralStation Software Temporary Monitoring Functionality Loss
FDA (Devices) · 2022-05-04
- HighDraegar Infinity Acute Care System Recall for Random Reboot Defect
FDA (Devices) · 2021-02-17
- HighDraeger Infinity M300 Telemetry Devices Recalled for Cybersecurity Vulnerabilities
FDA (Devices) · 2019-11-20
- HighDraeger Infinity Acute Care System Recalled for Cybersecurity Vulnerabilities
FDA (Devices) · 2019-11-06
- HighDraegar Medical Systems Recalls Omega Patient Monitor Software
FDA (Devices) · 2019-03-13
Same hazard · software anomaly
See all →- HighMiniMed 780G Insulin Pump Software Anomaly Recall
FDA (Devices) · 2026-07-15
- HighPlum Solo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Duo Precision IV pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- HighPlum Duo infusion pumps may not display soft limit alerts
FDA (Devices) · 2026-06-17
- SevereIvenix pump software may report false battery health and shut down
FDA (Devices) · 2026-06-10