Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta Recalled by Draegar Medical Systems, Inc. Due to The firm is recalling their Delta family of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Draegar Medical Systems, Inc. directly.
Affected Products
Infinity Delta Family patient monitors The Infinity Delta Series (Delta/Delta XL/Kappa) monitors are intended to be used on adult, pediatric, and neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcp02, which for the neonatal population, is to only be used when the patient is not under gas anesthesia.-Omega and Omega S are intended to be used on adult, pediatric, and neonatal populations.
Quantity: 10699 in total
Why Was This Recalled?
The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Draegar Medical Systems, Inc.
Draegar Medical Systems, Inc. has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report