GE Healthcare Optima MR45: Missing Slices Risk in 3D Imaging

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Contact the company & request your remedy

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 some Optima MR450w 1.5T MRI systems because software issues might cause missing slices in 3D images, potentially creating gaps in anatomical scans. This could affect the accuracy of medical imaging results.

Why it’s dangerous

The software version DV29.1 can cause some slices to be missing in 3D Volume images, creating gaps in anatomical structures. This may lead to incomplete or inaccurate medical imaging results, but does not pose a direct safety risk to patients or staff.

Who’s affected

Medical facilities using the Optima MR450w 1.5T MRI systems with software version DV29.1 are most affected. Patients undergoing scans with these systems may experience less accurate imaging results.

How to tell if you have this one

Check for the Optima MR450w 1.5T MRI system with software version DV29.1. This model is used for medical imaging and sold by GE Healthcare.

Brand
GE Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify the software version on your Optima MR450w 1.5T MRI system; if it is DV29.1, it is part of the recall.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

No, the recall is for potential imaging inaccuracies, not a direct safety risk. The hazard does not cause injury or death.

How can I tell if my system is affected?

Check if your Optima MR450w 1.5T MRI system has software version DV29.1.

What should I do if my system is affected?

Verify the software version; if it is DV29.1, contact GE Healthcare for guidance on next 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-0140-2022 — GE Healthcare GE Healthcare

Hello,

I own a GE Healthcare that is covered by recall Z-0140-2022 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-0140-2022 (August 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0140-2022 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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