GE Healthcare recalls SIGNA Horizon Cx, Horizon Lx, Infinity, MR/I, SmartSpeed, EchoSpeed Plus, and HighSpeed Plus MRI systems due to potential cryogen ventilation system failures. Affected units may require repair to prevent safety hazards.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Healthcare is recalling several MRI systems because their cryogen ventilation systems might not meet safety standards. This could lead to safety risks if the system fails to properly vent cryogens.
The MRI systems may have a cryogen ventilation system that doesn't meet required safety standards. This could cause the system to fail to properly vent cryogens, potentially leading to safety hazards in medical facilities.
Medical facilities using GE Healthcare SIGNA Horizon Cx, Horizon L: Infinity, MR/I, SmartSpeed, EchoSpeed Plus, or HighSpeed Plus MRI systems are most at risk. Patients and staff could face safety issues if the cryogen ventilation system fails.
Check if your MRI system is labeled as SIGNA Horizon Cx, Horizon Lx, Infinity, MR/I, SmartSpeed, EchoSpeed Plus, or HighSpeed Plus. These systems were sold by GE Healthcare for medical imaging.
Identify your MRI system model to confirm if it's affected by this recall.
Reach out to GE Healthcare for guidance on next steps if your system is affected.
The cryogen ventilation system may not meet safety standards, which could lead to potential safety hazards if the system fails to properly vent cryogens.
No, the recall does not require immediate discontinuation. Affected facilities should contact GE Healthcare for specific guidance.
Contact GE Healthcare directly for instructions on next steps, as the recall does not specify a repair or replacement timeline.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0617-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0617-2022 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.
