The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0138-2022·Announced 2021-10-27

GE Healthcare SIGNA Voyager MRI System Recall for Missing Image Slices

GE Healthcare is recalling the SIGNA Voyager nuclear magnetic resonance imaging system due to a software issue that can cause missing slices in 3D volume images, potentially creating gaps in anatomical information.

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: The device experiences a software defect resulting in missing slices in 3D volume images, creating gaps in diagnostic anatomical information. While this poses a risk of patient harm through incomplete diagnostic data, no illnesses or injuries have been reported. The FDA Class II classification without reported hospitalization supports a High severity rating under the rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

GE Healthcare, LLC is recalling the SIGNA Voyager nuclear magnetic resonance imaging system. The recall affects software versions VX29.1 and PX26.4 (China only) and involves 15 devices in total.

Under certain conditions, the imaging system may produce 3D volume images with missing slices, creating gaps in anatomical information. This defect could affect the completeness and accuracy of diagnostic imaging.

The affected devices were distributed in the United States to 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. Outside the United States, devices were distributed 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.

The recalled product

Product
SIGNA Voyager nuclear magnetic resonance imaging system
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Medical Imaging - MRI System
Hazard
Affected units
15

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 VX29.1
  • and PX26.4 (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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