Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Infinity Acute Care System (IACS) Monitoring System Recalled by Draeger Medical Systems, Inc. Due to Device is not in full compliance to Type...
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 Draeger Medical Systems, Inc. directly.
Affected Products
Infinity Acute Care System (IACS) Monitoring System, Infinity M500 with Power, Model No. MS20407. Rev 20, 21, and 23
Quantity: 34,102 units
Why Was This Recalled?
Device is not in full compliance to Type CF requirements of IEC 60601-1 and IEC 60601-2-34 standards. Therefore, there is a potential risk of electric shock. Health consequences may include electrical shock, burns, and cardiac arrhythmia.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Draeger Medical Systems, Inc.
Draeger Medical Systems, Inc. has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report