Draegar Infinity Acute Care System Recall for Random Reboot Defect
Draegar Medical Systems is recalling Infinity Acute Care System monitors that may randomly reboot due to a memory error, potentially interrupting patient monitoring.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a high-risk medical device where a malfunction could interrupt patient monitoring, representing a risk of harm even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Draegar Medical Systems, Inc. is recalling the Infinity Acute Care System (IACS) Monitoring Solution, specifically the Infinity M540 patient monitor. The recall affects 19,802 systems, including 3,412 units in the United States and 16,390 units distributed worldwide. The affected devices are Model Numbers MS25510, MS25520, and MS26372, Revisions 24 through 29.
The recall is due to a defect where the monitor may randomly reboot because of an error in transmitting and reading header data in the device's memory. When this occurs, the device attempts to reboot to mitigate the error and becomes available for use again within 30 seconds. If the error persists and the device reboots three times within 10 minutes, it enters a fail-state, indicated by a continuous sound. In this state, the device resets to factory defaults, requiring the user to manually configure the device and readmit the patient to continue monitoring.
The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where care is provided by trained healthcare professionals. Healthcare facilities should identify affected units and follow the recalling firm's instructions for remediation.
The recalled product
- Product
- Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric and neonatal patients in environments where patient care is provided by trained healthcare professionals.
- Manufacturer
- Draegar Medical Systems, Inc.
- Category
- Medical Device — Patient Monitor
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 (3)
- Model Number - MS25510
- MS25520
- MS26372 Revisions 24 to 29
Distribution
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