The Recall Desk
HighFDA (Devices)·Z-0141-2022·Announced 2021-10-27

MRI System Recall: GE Healthcare SIGNA HDxt Missing Image Slices

GE Healthcare is recalling the 1.5T SIGNA HDxt MR System due to a software issue that may cause missing slices in 3D volume images. Three devices distributed across the United States and internationally are affected.

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 medical device recall with no reported illnesses or injuries. The hazard—missing image slices that could compromise diagnostic accuracy—is theoretical without documented adverse outcomes. Per the rubric, this qualifies as High (3).

Plain-English summary

GE Healthcare, LLC is recalling the 1.5T SIGNA HDxt MR System, a nuclear magnetic resonance imaging system used for diagnostic medical imaging. Three devices are affected by this recall.

Under certain conditions, the affected systems may produce missing slices in 3D volume images, resulting in gaps of anatomical information. This software defect impacts versions HD29.1 and HD16.2.

The affected devices were distributed to healthcare facilities in the United States in 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. The systems were also distributed internationally to Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, United Arab Emirates, and the United Kingdom.

The recalled product

Product
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
Manufacturer
GE Healthcare, LLC
Category
Medical Device — MRI Imaging System
Hazard
Affected units
3

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 (2)

  • Software version HD29.1
  • and HD16.2 (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

Same manufacturer · GE Healthcare, LLC

See all →

Same hazard · missing slices

See all →