GE Healthcare recalls SIGNA HFO/I MRI systems due to potential cryogen ventilation system failures. Affected units may require repair to prevent safety risks.
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
GE Healthcare is recalling SIGNA HFO/I MRI systems because their cryogen ventilation systems might not meet safety standards. This could lead to safety issues if the system fails to properly vent cryogens.
The cryogen ventilation system might not meet safety standards, potentially causing cryogens to leak or not vent properly. This could lead to safety hazards in the MRI environment.
Medical facilities using GE Healthcare SIGNA HFO/I MRI systems are most at risk. Patients and staff could be affected if the system malfunctions.
Check if your MRI system has the GE Healthcare SIGNA HFO/I model name. All systems are affected, so no specific model numbers are excluded.
Reach out to GE Healthcare directly to confirm if your system is affected and get instructions for next steps.
Yes, all SIGNA HFO/I MRI systems are affected by this recall.
Contact GE Healthcare directly to confirm if your system is affected and get instructions for next steps.
The recall states potential cryogen ventilation system failures, but specific injury risks are not detailed in the official notice.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0606-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0606-2022 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
