The Recall Desk
HighFDA (Devices)·Z-3028-2017·Announced 2017-08-23

GE MRI Scanners Recalled for Potential Power Supply Shock Hazard

GE Medical Systems is recalling 68 MRI scanners due to possible incorrect wiring in the uninterruptible 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, fitting the High severity criteria.

Plain-English summary

GE Medical Systems, LLC is recalling 68 units of 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, and Signa Vibrant magnetic resonance imaging (MRI) scanners. 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 FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Healthcare facilities and users of these MRI scanners should contact GE Medical Systems for instructions on how to resolve the wiring issue. The recall number is Z-3028-2017.

The recalled product

Product
1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated fo
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 →

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Same hazard · shock hazard

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