The Recall Desk
HighFDA (Devices)·Z-3029-2017·Announced 2017-08-23

GE Medical Systems Recalls Signa PET/MR Systems Due to Shock Hazard

GE Medical Systems is recalling 68 Signa PET/MR systems because possible incorrect wiring of the Uninterruptable Power Supply could contribute to a potential 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 Signa PET/MR system (K163619, K142098). The recall is due to possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

The affected systems 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. The Signa PET/MR system combines magnetic resonance diagnostic devices and Positron Emission Tomography scanners to provide high-resolution physiologic and anatomic information.

Healthcare facilities should contact GE Medical Systems for instructions on how to resolve the wiring issue. The recall is classified as Class II by the FDA.

The recalled product

Product
Signa PET/MR (K163619, K142098) Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired
Manufacturer
GE Medical Systems, LLC
Category
Medical Device — Imaging Equipment
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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