Draeger recalls Infinity M500 monitoring systems (model MS20407, revisions 20-23) due to potential electric shock risk. Affected units may cause burns or cardiac issues. Contact for return instructions.
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.
Draeger is recalling specific models of its Infinity M500 monitoring systems because they may not meet safety standards, creating a risk of electric shock that could lead to burns or heart problems.
The device fails to meet electrical safety standards, which could allow electric current to flow through the patient or user. This might cause burns, shock, or heart rhythm problems if the device malfunctions.
Healthcare providers using the Infinity M500 monitoring systems with model number MS20407 and revisions 20, 21, or 23 are most at risk. Patients using these devices could experience electrical shock or cardiac issues.
Check for model number MS20407 and revisions 20, 21, or 23 on the device. The product was sold with a UDI-DI code 04049098054447.
Look for model number MS20407 and revisions 20, 21, or 23 on the device label.
Reach out to Draeger Medical Systems for return or repair instructions.
The device may not meet safety standards and could cause electric shock, burns, or heart issues. Do not use until contacted by Draeger.
Check for model number MS20407 and revisions 20, 21, or 23. The UDI-DI code 04049098054447 identifies affected units.
Contact Draeger Medical Systems for return or repair instructions. Do not use the device until you receive guidance.
We’ve drafted a message you can send Draeger to request your refund or repair — edit it as you like.
Subject: Recall Z-2189-2024 — Draeger Draeger Hello, I own a Draeger that is covered by recall Z-2189-2024 from Draeger. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
