Philips recalls Ingenia 1.5T Evoluton MRI systems with a faulty pressure relief valve that may release helium gas, causing injury. Affected units have specific model and serial numbers.
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 1.5T Evoluton MRI systems because a pressure relief valve installed at 42 psi instead of 3.75 psi could release helium gas, potentially causing injury. This recall affects specific model numbers and serial numbers listed in the notice.
The system has a pressure relief valve set to 42 psi instead of the required 3.75 psi. This higher pressure could cause helium gas to be released unexpectedly, potentially leading to injury.
Medical facilities using the Ingenia 1.5T Evoluton MRI systems are most at risk. Patients and staff could be affected if the system is used without proper safety checks.
Check for model number 781315 and serial numbers starting with US: 61044 or 61047. The system was sold with specific serial numbers listed in the recall notice.
Identify the model number (781315) and serial numbers starting with US: 61044 or 61047 to confirm if your system is affected.
The pressure relief valve is installed at 42 psi instead of the required 3.75 psi, which could cause helium gas to be released unexpectedly, potentially causing injury.
Check for model number 781315 and serial numbers starting with US: 61044 or 61047 as listed in the recall notice.
The recall notice does not specify a remedy, so contact Philips directly for further instructions.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2341-2021 — Philips Philips Hello, I own a Philips that is covered by recall Z-2341-2021 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.
