The Recall Desk
HighFDA (Devices)·Z-3027-2017·Announced 2017-08-23

GE Signa MRI Systems Recalled for Potential Shock Hazard

GE Medical Systems is recalling 68 Signa MRI systems due to possible incorrect wiring in the Uninterruptable Power Supply, which could create a shock hazard.

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 product (shock hazard) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

GE Medical Systems, LLC is recalling 68 units of GE Signa MRI systems, including the 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, and Signa Vibrant models. The recall is due to a possible incorrect wiring of the Uninterruptable Power Supply (UPS), which could contribute to a potential shock hazard.

The affected units were distributed nationwide in the United States, specifically in the states of AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI. The recall is classified as Class II by the FDA.

Healthcare facilities and users of these MRI systems should contact GE Medical Systems for instructions on how to resolve the wiring issue. The source text does not report any specific injuries or illnesses associated with this defect.

The recalled product

Product
1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa¿ H
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — MRI Scanner
Hazard
Affected units
68

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)

  • Medical Device Listing No. D117354
  • D295466
  • D182389
  • D102432
  • D206140
  • D230310
  • D269569
  • D102430
  • D140572
  • D188736
  • D102434
  • D234841
  • D196247
  • D134019
  • D236543
  • D006275
  • D159181
  • D288890
  • D229859
  • Model No. Eaton 9130

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

Related recalls

Same manufacturer · GE Medical Systems, LLC

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Same hazard · shock hazard

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