The Recall Desk
HighFDA (Devices)·Z-2872-2018·Announced 2018-08-29

GE Healthcare Optima CT540 Systems Recalled for Damaged Cable Hazard

GE Healthcare is recalling Optima CT540 systems because a damaged cable may expose 120VAC to service engineers working inside the gantry.

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 (electrical shock hazard) where injury has not yet been reported, which aligns with the High severity criteria in the rubric.

Plain-English summary

GE Healthcare Japan Corporation is recalling GE Healthcare Optima CT540 systems. The recall involves 4,007 devices distributed worldwide, including nationwide distribution across the United States.

The recall was initiated because some of these CT systems may have a damaged cable that can expose 120VAC to service engineers working inside the gantry. The systems are intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications.

Service engineers should be aware of the potential electrical hazard when working inside the gantry of these specific systems. The source text does not provide specific instructions for consumers or patients, as the hazard is directed at technical personnel.

The recalled product

Product
GE Healthcare Optima CT540. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.Sold under the following product names: BEIJING CT OPTIMA 540, BEIJING OPTIMA, BEIJING OPTIMA 540, BEIJING OPTIMA 540 ASIR, CT BEIJING OPTIMA
Manufacturer
GE Healthcare Japan Corporation
Category
Medical Device — Computed Tomography
Hazard

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)

  • Model Number
  • Serial Number (System ID): 5432539
  • 00000409871HM1 (IR1304CT02)
  • 5432539
  • 00000406425HM9 (IR1563CT01)
  • 5432539-2
  • Not Available (970GMCT1)
  • 343769HM6 (262434OPTCT1)
  • 383019HM7 (251809DWMCT)
  • 00000058405YC2 (928289CT)
  • 00000340698HM0 (TMCACT540)
  • 340698HM0 (AM16OG71165)
  • 377682HM0 (850314CT)
  • 00000333256HM6 (954916OPT16)
  • 00000350436HM2 (912466OCT)
  • 00000354310HM5 (770382ERCT)
  • 00000361670HM3 (919956CT)
  • 00000370798HM1 (704403KAN)
  • 00000358402HM6 (910642CT2)
  • 00000348412HM8 (SJRCT540)

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Part of a larger recall action

This product is one of 4 recalled by GE Healthcare Japan Corporation 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 4 products in this recall →

Related recalls

Same manufacturer · GE Healthcare Japan Corporation

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Same hazard · electrical shock

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