Philips recalls Achieva 3.0T MRI systems with faulty pressure relief valve that may release helium gas, causing injury. Affected units have model number 781277 (OUS).
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 Achieva 3.0T MRI systems that have a pressure relief valve set to 42 psi instead of the required 3.75 psi. This faulty valve could release helium gas, potentially causing injury during use.
The system's pressure relief valve is set to 42 psi instead of the required 3.75 psi. This higher pressure could cause the valve to release helium gas unexpectedly, potentially leading to injury.
Medical facilities using Philips Achieva 3.0T MRI systems with model number 781277 (OUS) are affected. Patients and staff at these facilities are at risk if the system malfunctions.
Check for model number 781277 (OUS) on the Achieva 3.0T MRI system. The system is designed for diagnostic imaging and has no serial number or UDI.
Verify the pressure relief valve is set to 3.75 psi by contacting Philips support.
Yes, patients at facilities using the affected systems are at risk if the valve malfunctions.
Look for model number 781277 (OUS) on the Achieva 3.0T MRI system. The system has no serial number or UDI.
Contact Philips support to verify the valve pressure setting; they may need to adjust it to 3.75 psi.
We’ve drafted a message you can send Philips to request your refund or repair — edit it as you like.
Subject: Recall Z-2346-2021 — Philips Philips Hello, I own a Philips that is covered by recall Z-2346-2021 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.
