The Recall Desk
HighFDA (Devices)·Z-3026-2017·Announced 2017-08-23

GE Medical Systems Recalls MRI Scanners Due to Power Supply Wiring

GE Medical Systems is recalling 68 MRI scanners 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 the 1.5T SIGNA Creator and 1.5T SIGNA Explorer whole body magnetic resonance scanners. These diagnostic imaging devices are indicated for use in producing various images of the body's structures and functions.

The recall is being issued because of possible incorrect wiring in the Uninterruptable Power Supply (UPS). This defect could contribute to a potential shock hazard for users or patients.

The affected units were distributed nationwide 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. Users of these devices should contact GE Medical Systems for instructions on how to resolve the wiring issue.

The recalled product

Product
SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to prod
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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