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Lower risk Medical device recall · FDA · Published August 26, 2021

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

GE Healthcare recalls SIGNA Pioneer MRI systems with software versions PX29.1 and PX25.4 (T) that may show missing slices in 3D images, potentially causing anatomical gaps in scans.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0134-2022Medical deviceGE Healthcare ›
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Recalling firmGE Healthcare, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
✎ GovInfoNow plain-language explainer

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). Read more at govinfonow.com/recall/61884-ge-healthcare-signa-pioneer-mri-missing-slices-risk-gap-in.

Source Summary by GovInfoNow · govinfonow.com/recall/61884-ge-healthcare-signa-pioneer-mri-missing-slices-risk-gap-in · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0134-2022

Cite this page

“GE Healthcare SIGNA Pioneer MRI: Missing Slices Risk Gap in 3D Images.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61884-ge-healthcare-signa-pioneer-mri-missing-slices-risk-gap-in. Based on FDA recall #Z-0134-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0134-2022%22&limit=1).

GE Healthcare LLC recalled SIGNA Pioneer nuclear magnetic resonance imaging systems on Aug. 26, 2021, according to the FDA. The devices may produce images with missing slices, creating gaps in 3D volume anatomy. The recall involves five units distributed in the United States and internationally.

How to tell if you have it

  • Brand: GE Healthcare
  • Product: SIGNA Pioneer nuclear magnetic resonance imaging system
  • Software versions: PX29.1; PX25.4 (T); PX28.3 (China only)
  • Quantity: 5 devices

The hazard

Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images, according to the FDA.

Context

GovInfoNow's records show GE Healthcare LLC has 97 other recalls on record since Oct. 4, 2017. Other recent recalls of similar products include GE Healthcare SIGNA Premier MRI Scanners May Have Steel Fittings Risking Injury (Feb. 27, 2026), GE Centricity Universal Viewer 6.0/7.0/8.0: Inaccurate Distance Measurements (July 15, 2022), and GE Healthcare SIGNA Premier MRI Scanner Recall: Risk of Hearing Loss from Acoustic Noise (June 24, 2022). Other recent recalls of similar products include GE Medical Systems Senographe Pristina Mammography Machines: Missing X-Ray Warning Label (Oct. 24, 2025).

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
FDA recall event · 10 products

All 10 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK
Recall numberProduct, codes & lotsQuantity
Z-0132-2022SIGNA Premier nuclear magnetic resonance imaging system; Software version RX29.1 and RX27.3 (China only)11 devices
Z-0133-2022SIGNA Architect nuclear magnetic resonance imaging system; Software version DV29.1; and DV28.4 (F), DV27.3 (T) (China only)2 devices
Z-0134-2022SIGNA Pioneer nuclear magnetic resonance imaging system; Software version PX29.1; and PX25.4 (T), PX28.3 (China only)5 devices
Z-0135-2022Discovery MR750w 3.0T nuclear magnetic resonance imaging system; Software version DV29.113 devices
Z-0136-2022Discovery MR750 3.0T nuclear magnetic resonance imaging system; Software version DV29.15 devices
Z-0137-2022SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system; Software version DV29.16 devices
Z-0138-2022SIGNA Voyager nuclear magnetic resonance imaging system; Software version VX29.1; and PX26.4 (China only)15 devices
Z-0139-2022SIGNA Artist nuclear magnetic resonance imaging system; Software version DV29.118 devices
Z-0140-2022Optima MR450w 1.5T nuclear magnetic resonance imaging system; Software version DV29.113 devices
Z-0141-20221.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system; Software version HD29.1; and HD16.2 (China only)3 devices
Based on the official FDA remedy

What to do — step by step

  1. 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.

Where it went and when

Where it was distributed

Distributed in 18 states and Puerto Rico, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: yesNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Florida, Georgia, Illinois, Louisiana, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Puerto Rico, Texas, Virginia, Washington.

Recall timeline

FDA terminated this recall 4.7 years after the firm started it.

1. Firm started the recall: Aug 26, 202112. FDA classified it Class II: Oct 16, 202123. Published in FDA’s Enforcement Report: Oct 27, 202134. FDA terminated the recall: May 4, 2026420212026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA