GE Healthcare recalls SIGNA Premier MRI systems due to potential cryogen ventilation system failures. This could lead to unsafe conditions in the imaging environment.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Healthcare is recalling its SIGNA Premier MRI systems because the cryogen ventilation system might not meet safety requirements. This could create unsafe conditions in the imaging environment.
The cryogen ventilation system in these MRI systems might not meet required safety standards. This could lead to unsafe conditions in the imaging environment, though the risk is not described as causing serious injury.
Users of GE Healthcare SIGNA Premier MRI systems are affected. Medical facilities using these systems are most at risk.
This recall applies to all GE Healthcare SIGNA Premier MRI systems. The product is a component of the nuclear magnetic resonance imaging system.
Identify if your MRI system is part of the GE Healthcare SIGNA Premier system.
The recall states potential issues with the cryogen ventilation system, but does not specify a risk of serious injury or death.
The recall does not provide a specific remedy, so no action is required at this time.
This recall applies to all GE Healthcare SIGNA Premier MRI systems.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0590-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0590-2022 from GE Healthcare. 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.
