The Recall Desk
HighFDA (Devices)·Z-0134-2022·Announced 2021-10-27

GE SIGNA Pioneer MRI Recall for Missing Image Slices

GE Healthcare is recalling 5 SIGNA Pioneer MRI systems where a software issue can cause missing image slices in 3D volume scans. This may lead to diagnostic gaps.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device recall with no reported illnesses or injuries. The hazard involves diagnostic imaging quality (missing image slices), representing a risk of patient harm through potential misdiagnosis, but no actual injuries have been reported.

Plain-English summary

GE Healthcare, LLC is recalling 5 SIGNA Pioneer MRI systems due to a software issue that can cause missing image slices in 3D volume imaging studies. Affected versions include PX29.1, PX25.4 (T), and PX28.3 (China only).

Under certain conditions, some slices may be missing from 3D volume images, creating gaps in anatomical coverage and potentially affecting diagnostic quality and accuracy.

The affected systems were distributed throughout the United States (including Arizona, California, Florida, Georgia, Illinois, Louisiana, Massachusetts, Maryland, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Texas, Virginia, Washington, and Puerto Rico) and internationally to Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, the United Arab Emirates, and the United Kingdom.

Customers using affected systems should contact GE Healthcare for information on software updates or other corrective measures.

The recalled product

Product
SIGNA Pioneer nuclear magnetic resonance imaging system
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging / MRI
Hazard
Affected units
5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Software version PX29.1
  • and PX25.4 (T)
  • PX28.3 (China only)

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 10 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Related recalls

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Same hazard · diagnostic inaccuracy

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