GE Healthcare 3.0T SIGNA Infinity TwinSpeed MRI Recall: Cryogen Venting Risk

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Contact the company & request your remedy

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 certain 3.0T SIGNA Infinity Twin: TwinSpeed MRI systems because their cryogen ventilation systems might not meet safety standards. This could lead to safety issues if the system fails during operation.

Why it’s dangerous

The cryogen ventilation system in these MRI machines might not properly vent refrigerant gases. If this system fails, it could lead to unsafe conditions inside the MRI room during operation.

Who’s affected

Medical facilities using GE Healthcare's 3.0T SIGNA Infinity TwinSpeed MRI systems are most at risk. Patients and staff could be affected if the system malfunctions during imaging procedures.

How to tell if you have this one

Check if your MRI system is labeled as GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System. All units are affected by this recall.

Brand
GE Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Label
Look for the model name 'GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System' on the device.

✎ GovInfoNow

Questions people ask

Is there a fix for this issue?

The recall record does not specify a remedy or fix.

How can I tell if my MRI system is affected?

Check if your system is labeled as GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System.

What should I do if I have this system?

The recall record does not specify a remedy or action steps.

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-0613-2022 — GE Healthcare GE Healthcare

Hello,

I own a GE Healthcare that is covered by recall Z-0613-2022 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-0613-2022 (December 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0613-2022 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.

GE Healthcare, LLC recalls GE Healthcare MR superconducting magnets, a component of GE 3.0T SIGNA Infinity TwinSpeed with Excite MR System,

Use caution until it’s fixed