The Recall Desk
HighFDA (Devices)·Z-3022-2017·Announced 2017-08-23

GE Medical Systems Recalls Optima MR450 1.5T Scanners for Wiring Defect

GE Medical Systems is recalling 68 Optima MR450 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 risk-of-harm product (shock hazard) where injury has not yet been reported, fitting the High severity criteria for medical devices with potential but unreported harm.

Plain-English summary

GE Medical Systems, LLC is recalling 68 units of the Optima MR450 1.5T magnetic resonance (MR) scanner. The recall is due to a possible incorrect wiring issue 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 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, indicating a situation where use of, or exposure to, a 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 devices should contact GE Medical Systems to arrange for inspection and correction of the wiring. The recall number is Z-3022-2017.

The recalled product

Product
Optima MR450 1.5T Product Usage: 1 .5T Brivo MR355 and 1.5T Optima MR360 are whole body magnetic resonance scanners 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,
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

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Same hazard · shock hazard

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