Philips recalls Ingenia Elition S MRI systems with faulty pressure relief valve that may release helium gas, causing injury. Affected units have specific model numbers and serial codes.
Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
Philips is recalling Ingenia Elition S MRI systems that have a pressure relief valve set to 42 psi instead of the required 3.75 psi. This could cause helium gas to be released, potentially leading to injury. The recall affects specific model numbers and serial codes.
The pressure relief valve is set to 42 psi instead of the required 3.75 psi. This higher pressure could cause helium gas to be released, which might lead to injury if the system is used improperly.
Medical facilities using the Ingenia Elition S MRI systems are most at risk. Patients and staff could be affected if the system malfunctions.
Check for model numbers 781357 (OUS) and serial numbers starting with 46083, 46084, 46086, 46054, or 46058, or 46082, 46061.
Look for model number 781357 (OUS) and serial numbers starting with 46083, 46084, 46086, 46054, 46058, or 46082, 46061.
The model number is 781357 (OUS).
The valve being set to 42 psi instead of 3.75 psi may cause helium gas to be released, potentially causing injury.
Check for model number 781357 (OUS) and serial numbers starting with 46083, 46084, 46086, 46054, 46058, or 46082, 46061.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2347-2021 — Philips Philips Hello, I own a Philips that is covered by recall Z-2347-2021 from Philips. 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.
