GE Healthcare recalls 1.5T and 3.0T MRI systems due to potential cryogen ventilation system failures. Affected units may pose risks if not properly vented.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Healthcare is recalling certain MRI systems that include superconducting magnets. The recall is due to a potential issue with the cryogen ventilation system, which could lead to safety risks if not properly maintained.
The cryogen ventilation system may not meet required venting standards. This could cause improper release of cryogenic fluids, potentially leading to safety hazards in the MRI environment.
Medical facilities using GE SIGNA Excite 1.5T or 3.0T MRI systems are likely affected. Patients and staff at these facilities are at risk if the ventilation system fails.
Check for GE SIGNA Excite 1.5T or 3.0T MRI systems. The recall applies to all units of these systems.
Identify if your MRI system is a GE SIGNA Excite 1.5T or 3.0T model.
The recall is due to potential issues with the cryogen ventilation system that may not meet venting requirements.
The recall does not specify a remedy, so contact GE Healthcare for further instructions.
The recall states a potential risk but does not specify injury mechanisms or severity.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0615-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0615-2022 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.
