The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0133-2022·Announced 2021-10-27

MRI System Software Defect May Cause Missing Anatomical Image Data

GE Healthcare's SIGNA Architect MRI system may fail to generate complete image slices under certain software conditions, resulting in gaps within 3D volume images that could affect diagnostic imaging integrity.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical device recall with a functional defect impacting diagnostic imaging quality. This represents a risk-of-harm product where injury has not been reported, meeting the rubric criteria for Score 3.

Plain-English summary

GE Healthcare's SIGNA Architect nuclear magnetic resonance imaging system is the subject of a Class II recall. Two devices with software versions DV29.1, DV28.4 (F), or DV27.3 (T) are affected.

Under certain conditions, these systems may fail to generate all required image slices, resulting in gaps within the 3D volume images. This missing anatomical data could impact the completeness of diagnostic imaging studies.

The affected devices have been distributed in the United States across multiple states and Puerto Rico, as well as internationally including Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, the United Arab Emirates, and the United Kingdom.

The recalled product

Product
SIGNA Architect nuclear magnetic resonance imaging system
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
2

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 DV29.1
  • and DV28.4 (F)
  • DV27.3 (T) (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 →

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