Philips recalls Ingenia Elition X-MRI systems with faulty pressure relief valve that may release helium gas, causing injury. Affected units have specific model and serial numbers. Consumers should contact Philips for details.
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 X-MRI systems that have a pressure relief valve set to 42 psi instead of the correct 3.75 psi. This could cause helium gas to be released, potentially leading to injury. Affected units have specific model and serial numbers.
The pressure relief valve in the magnet assembly is installed at 42 psi instead of the required 3.75 psi. This higher pressure could cause helium gas to be released, potentially leading to injury. The risk is specific to the MRI environment where helium is used.
Medical facilities using the Ingenia Elition X-MRI systems are most at risk. Patients and staff who use these systems may be affected if the faulty valve releases helium gas.
Check for model number 781358 on the system. Serial numbers and UDI codes include specific patterns like US: 45245 (01)00884838088115(21)45245.
Reach out to Philips for specific details about your unit and instructions on how to proceed.
The model number is 781358.
Check for model number 781358 and serial numbers starting with US: 45245, 45247, 45261, 45263, 45264, 45269, or OUS: 45215, 45284, 45253, 45313, 45265, 45297, 45218, 45272, 45281, 45231, 45278, 45279, 45245, 45247.
Contact Philips directly for details about your specific unit and instructions on how to proceed.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2344-2021 — Philips Philips Hello, I own a Philips that is covered by recall Z-2344-2021 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.
