GE Healthcare SIGNA Pioneer MRI: Missing Slices Risk Gap in 3D Images

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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 some SIGNA Pioneer MRI systems that may show missing slices in 3D images, which could create gaps in anatomical scans. This issue affects the software versions PX29.1 and PX2:5.4 (T) and PX28.3 (China only).

Why it’s dangerous

The software may cause some slices to be missing in 3D volume images, creating gaps in anatomical structures. This could lead to less accurate scans but does not pose a direct safety risk.

Who’s affected

Patients and medical staff using the SIGNA Pioneer MRI systems with specific software versions are affected. The risk is low as the issue only affects image quality, not safety.

How to tell if you have this one

Check if your SIGNA Pioneer MRI has software version PX29.1 or PX25.4 (T) in the United States, or PX28.3 in China. The product is a nuclear magnetic resonance imaging system.

Brand
GE Healthcare
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Identify your MRI's software version to see if it matches PX29.1 or PX25.4 (T) in the US, or PX28.3 in China.

✎ GovInfoNow

Questions people ask

What software versions are affected?

Software versions PX29.1 and PX25.4 (T) in the US, and PX28.3 in China.

Is this a safety hazard?

No, this issue only affects image quality and does not pose a safety risk.

How can I check if my MRI is affected?

Check the software version on your SIGNA Pioneer MRI system; affected versions are PX29.1, PX25.4 (T), or PX28.3 (China).

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-0134-2022 — GE Healthcare GE Healthcare

Hello,

I own a GE Healthcare that is covered by recall Z-0134-2022 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-0134-2022 (August 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0134-2022 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 SIGNA Pioneer nuclear magnetic resonance imaging system

Lower-risk recall