GE Healthcare SIGNA 1.5T TwinSpeed MR System: Cryogen Venting Risk

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Recalling firmGE Healthcare, LLC3000 N Grandview Blvd, N/A · Waukesha, WI 53188-1615

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

GE Healthcare is recalling its SIGNA 1. 5T TwinSpeed MR systems because the cryogen ventilation system might not meet safety standards. This could pose health risks if the system fails to vent properly.

Why it’s dangerous

The cryogen ventilation system might not meet required venting standards. This could lead to improper release of cryogenic fluids, potentially causing health hazards if the system fails.

Who’s affected

Medical facilities using GE Healthcare SIGNA 1.5T TwinSpeed MR systems are likely affected. Patients and staff near the system during a failure could be at risk.

How to tell if you have this one

Check if you own a GE Healthcare SIGNA 1.5T TwinSpeed MR system. All systems are affected, but the specific model is not listed in the recall.

Brand
GE Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Status
Verify if your system has the GE Healthcare SIGNA 1.5T TwinSpeed MR model.

✎ GovInfoNow

Questions people ask

Is there a fix for this issue?

The recall record does not mention a remedy or fix.

How can I tell if my system is affected?

All GE Healthcare SIGNA 1.5T TwinSpeed MR systems are affected, but the specific model details are not listed in the recall.

What should I do if I have this system?

The recall record does not specify any action steps or remedies.

Take action

Contact GE Healthcare

We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0604-2022 — GE Healthcare GE Healthcare

Hello,

I own a GE Healthcare that is covered by recall Z-0604-2022 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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Where this comes from

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.

Official source: FDA Recall #Z-0604-2022 (December 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0604-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

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