The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0112-2019·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 worldwide because software issues may cause 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 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 recall is classified as FDA Class II, and the hazard involves potential diagnostic errors (image flipping/data mismatch) which poses a risk of harm, but no injuries or illnesses have been reported in the source text.

Plain-English summary

GE Medical Systems, LLC is recalling approximately 5,200 GE Healthcare MRI systems sold under various product names, including 1.5T and 3.0T models. The affected units are equipped with Software Version 15.x or HD 16. The recall covers systems distributed worldwide, including the United States and numerous international markets.

The recall is due to a software issue where the latest on-site software version may not have been reinstalled at some sites after service activities were performed. This defect can result in images being flipped left/right and/or patient data mismatches. These errors could potentially lead to incorrect clinical interpretations or administrative errors.

Healthcare facilities should contact GE Medical Systems to verify the software status of their MRI systems and ensure the correct version is installed. Patients who have had recent MRI scans on affected systems should consult their healthcare providers to review the accuracy of their images and associated data.

The recalled product

Product
GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX…
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
  • 000000000R7742 (MP697620)
  • N/A
  • 00000834BD4B76 (M2865810)
  • 46-294231G1
  • 0002005-0607-9 (80040MRS02)
  • 00000293242MR4 (GOLD00EU79)
  • 5127452
  • 00000274388MR8 (M4160077)
  • 2226300
  • 000000000R7586 (PL2130MR01)
  • 000000000R2785 (A5106403)
  • N/A (083027060000499)
  • 000000000R5870 (A5177224)
  • 000000000R4933 (C4194430)
  • 000000000R7628 (PL1807MR01)
  • 5911000-4
  • 00001201FMM0FJ (083027829345912)
  • 000000000R5979 (818713MR1)

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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