The Recall Desk
HighFDA (Devices)·Z-0111-2019·Announced 2018-10-24

GE Healthcare MRI Systems Software Recall - On-Site Software Not Reinstalled

GE Medical Systems is recalling MRI systems because the latest software version was not properly reinstalled after service, potentially causing image flipping and patient data mismatch.

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: The recall involves a risk-of-harm medical device (MRI systems) where injury has not yet been reported, fitting the High severity criterion for risk-of-harm products without confirmed injury. Although no deaths or serious injuries are documented, the potential for inaccurate diagnostic imaging due to improper software reinstallation warrants a High severity rating.

Plain-English summary

The U.S. Food and Drug Administration is recalling GE Healthcare MRI systems (Software Version 12.x) due to a software recall identified during service activities. The issue involves the possibility that the latest on-site software version was not reinstalled at some locations after service work was completed, which may result in images appearing flipped left/right and/or patient data becoming mismatched.

These MRI systems are used in healthcare facilities worldwide, including across all 50 U.S. states and numerous international countries. The recall affects approximately 5,200 total units distributed globally. While the recall addresses a software versioning problem rather than a direct physical malfunction, the potential for inaccurate diagnostic imaging represents a risk-of-harm scenario.

Consumers and healthcare providers should contact their facility management to confirm whether their specific MRI system is affected and follow any provided instructions regarding software updates or recalibration. Facilities should ensure proper reinstallation of the software version to restore correct imaging functionality and prevent potential patient care issues.

The recalled product

Product
GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Medical Imaging
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) : 2226300
  • 000000000R4938 (256329MR2)
  • 2226300
  • 000000000R5598 (256ALOPMR)
  • N/A
  • N/A (334699MR)
  • 2377062-2
  • 00000002547YR8 (256265HMR)
  • 5107849
  • 00000274691MR5 (205487MR2)
  • 46-294231G1
  • 0002005-0411-5 (870972E16)
  • 002005-1201-35 (623583MR1)
  • 00000963660YM6 (480323MR1)
  • 5107849-2
  • 00000278561MR6 (818445MR)
  • 002004-1028-04 (3825)
  • 2377062
  • 00000941225YM5 (626335MR)

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 →

Related recalls

Same manufacturer · GE Medical Systems, LLC

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Same hazard · software error

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