The Recall Desk
HighFDA (Devices)·Z-3024-2017·Announced 2017-08-23

GE Optima MR450w 1.5T MRI Scanner Recalled for Potential Shock Hazard

GE Medical Systems is recalling 68 Optima MR450w 1.5T 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 potential electrical shock hazard, which is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Medical Systems, LLC is recalling 68 units of the Optima MR450w 1.5T whole body magnetic resonance scanner. The recall is due to a possible incorrect wiring issue in the Uninterruptable Power Supply (UPS) component. This defect could contribute to a potential electrical shock hazard for users or patients.

The affected units were distributed nationwide in the United States, specifically in the states of Alaska, California, Colorado, Connecticut, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Missouri, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Texas, Washington, and Wisconsin. The recall is classified as Class II by the FDA, indicating that the defect could cause temporary or medically reversible health consequences.

Healthcare facilities and consumers with these specific MRI scanners should contact GE Medical Systems for instructions on how to resolve the wiring issue. The recall number is Z-3024-2017. Users should verify their specific model and serial numbers against the provided listing numbers to determine if their unit is affected.

The recalled product

Product
Optima MR450w 1.5T Product Usage: The Optima MR450w 1.5T system 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 produce axial, sagittal,
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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