The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0132-2022·Announced 2021-10-27

MRI System Software Defect Causes Missing Image Slices

GE Healthcare is recalling 11 SIGNA Premier MRI systems. Under certain conditions, software versions RX29.1 and RX27.3 can cause missing slices in 3D imaging, creating gaps in anatomical data clinicians use for diagnosis.

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 with no reported injuries or hospitalizations. The hazard—missing imaging slices that could impair diagnostic accuracy—is theoretical. Per the severity rubric, risk-of-harm products without reported injury score at most 3 (High).

Plain-English summary

GE Healthcare, LLC is recalling 11 SIGNA Premier nuclear magnetic resonance (MRI) imaging systems used for clinical diagnosis. The affected systems operate software versions RX29.1 and RX27.3 (China market only).

Under certain conditions, the software defect causes some image slices to be missing from 3D Volume imaging data. This results in gaps in the anatomical representation available to clinicians. If these gaps are not detected, clinicians may base diagnostic and treatment decisions on incomplete imaging information.

The affected systems are distributed to healthcare facilities in 19 U.S. states, Puerto Rico, and 16 countries outside the United States (Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, United Arab Emirates, and United Kingdom). Healthcare providers with affected systems should contact GE Healthcare for information about software corrections or replacement options.

The recalled product

Product
SIGNA Premier nuclear magnetic resonance imaging system
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
Hazard
Affected units
11

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 (1)

  • Software version RX29.1 and RX27.3 (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 →

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