GE Healthcare 0.7T SIGNA OpenSpeed MRI System Recall: 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 0.7T SIGNA OpenSpeed MRI systems due to potential issues with cryogen ventilation. This could lead to safety risks if the system is not properly vented.

Why it’s dangerous

The cryogen ventilation system might not meet required venting standards. This could cause safety hazards if the system is not properly maintained or ventilated.

Who’s affected

Medical facilities using GE Healthcare's 0.7T SIGNA OpenSpeed MRI systems are most at risk. Patients and staff could be affected if the ventilation issue is not resolved.

How to tell if you have this one

Check for GE Healthcare 0.7T SIGNA OpenSpeed MRI systems. All units are affected, but the specific model is part of the GE 0.7T SIGNA OpenSpeed with Excite MR System.

Brand
GE Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Ventilation
Ensure the cryogen ventilation system meets venting requirements as per manufacturer guidelines.

✎ GovInfoNow

Questions people ask

Is this recall affecting all GE 0.7T SIGNA OpenSpeed MRI systems?

Yes, all units of the GE 0.7T SIGNA OpenSpeed with Excite MR System are affected.

What should I do if I have this MRI system?

Check if your system's cryogen ventilation meets venting requirements and ensure proper maintenance.

Is there a specific fix for this issue?

The recall record does not specify a fix or remedy.

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-0608-2022 — GE Healthcare GE Healthcare

Hello,

I own a GE Healthcare that is covered by recall Z-0608-2022 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-0608-2022 (December 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0608-2022 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 0.7T SIGNA OpenSpeed with Excite MR System, nuclear

Use caution until it’s fixed