The Recall Desk
HighFDA (Devices)·Z-3021-2017·Announced 2017-08-23

GE Brivo and Optima MRI Scanners Recalled for Power Supply Wiring

GE Medical Systems is recalling 68 Brivo MR355 and Optima MR360 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, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

GE Medical Systems, LLC is recalling 68 units of the Brivo MR355 and Optima MR360 whole body magnetic resonance 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 recall is classified as Class II by the FDA.

Healthcare facilities should contact GE Medical Systems for instructions on how to correct the wiring issue. The source text does not report any injuries or illnesses associated with this defect.

The recalled product

Product
Brivo MR355, Optima MR360 Product Usage: The Brivo MR355/Optima MR360 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, sag
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Diagnostic Imaging
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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