GE Healthcare Optima MR450w 1.5T: Cryogen Venting Risk

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

GE Healthcare is recalling its Optima MR450w 1.5T MRI systems because the cryogen ventilation system might not meet safety standards. This could lead to safety issues if the system fails to properly vent cryogens.

Why it’s dangerous

The cryogen ventilation system in these MRI systems might not meet required safety standards. If the system fails to properly vent cryogens, it could create a safety hazard.

Who’s affected

Medical facilities using GE Healthcare Optima MR450w 1.5T MRI systems are likely affected. Staff and patients using these systems could be at risk if the ventilation system fails.

How to tell if you have this one

Check if you own a GE Healthcare Optima MR450w 1.5T or Optima MR450w GEM system. The recall applies to all units of this model.

Brand
GE Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check System Model
Identify your MRI system model to confirm if it is affected by this recall.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

The recall states there is a potential risk, but the exact danger level is not specified in the record.

What should I do if I have this system?

The recall record does not provide specific action steps for affected systems.

How can I confirm if my system is affected?

Check if your system is listed as GE Healthcare Optima MR450w 1.5T or Optima MR450w GEM.

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-0601-2022 — GE Healthcare GE Healthcare

Hello,

I own a GE Healthcare that is covered by recall Z-0601-2022 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-0601-2022 (December 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0601-2022 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 Healthcare Optima MR450w 1.5T, Optima MR450w GEM system,

Recall notice