The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0110-2019·Announced 2018-10-24

GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch

GE Medical Systems is recalling 5,200 MRI systems with software version 11.x because service activities may have failed to reinstall the latest software, potentially causing flipped images or patient data mismatches.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard involves diagnostic image errors and data mismatches rather than direct physical injury or death, fitting the Moderate severity criteria for low-risk contamination or software defects without reported serious harm.

Plain-English summary

GE Medical Systems, LLC is recalling 5,200 GE Healthcare MRI systems equipped with software version 11.x. The affected units were distributed worldwide, including across the United States and numerous international countries. The recall involves various 1.5T and 3.0T MRI models, such as the Signa Excite and Signa EchoSpeed series.

The recall was initiated because the latest on-site software version may not have been reinstalled at some sites after service activities were performed. This software issue can result in images being flipped left and right and/or cause patient data mismatches. These errors could compromise the accuracy of diagnostic imaging and patient records.

Healthcare facilities and consumers should contact GE Medical Systems to verify if their MRI system is affected and to ensure the correct software version is installed. The source text does not specify a deadline or additional consumer actions beyond the recall notification.

The recalled product

Product
GE Healthcare MRI Systems, Software Version 11.x, sold under the following product names: 1.5T CXK4 LCC MAGNET,1.5T EXCITE, 1.5T EXCITE E/S, 1.5T EXCITE GS, 1.5T EXCITE HYBRID, 1.5T EXCITE TWIN, 1.5T EXCITE UPGRAD, 1.5T HD ES/HS TR W/EXCITE, 1.5T MR MOBILE (SERIAL #…
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — MRI Systems
Hazard
Affected units
5,200

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 (20)

  • Model Number
  • Serial Number (System ID) : N/A
  • 002003-0530-08 (GOLD010252)
  • 46-294231G1
  • 002004-0406-06 (HC5300MR02)
  • 000004-0311-16 (IE1053MR01)
  • 2377062-2
  • 00000963562YM4 (0850270477)
  • 2377062
  • 00000983439YM5 (0850270470)
  • 002002-1021-51 (0850270122)
  • 0000099-0809-8 (482180SIGNA)
  • 00000941219YM8 (561863MR1)
  • N/A
  • N/A (0910272059)
  • 2226300
  • 000000000R1040 (PL1124MR02)
  • 0002005-0922-4 (00491MRS01)
  • N/A (083027200000913)
  • 963531YM9 (559713CMIMR)

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 3 recalled by GE Medical Systems, 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 3 products in this recall →

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