The Recall Desk
HighFDA (Devices)·Z-2871-2018·Announced 2018-08-29

GE Healthcare Optima CT660 Recall for Damaged Cable Electrical Hazard

GE Healthcare is recalling Optima CT660 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 electrical shock (120VAC exposure) to service engineers, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

GE Healthcare Japan Corporation is recalling 4,007 GE Healthcare Optima CT660 CT systems. The recall is due to a potential defect where a damaged cable may expose 120VAC to service engineers working inside the gantry.

The affected devices were distributed worldwide, including in the United States and numerous international countries. The source text does not report any injuries or illnesses associated with this defect.

Service engineers should be aware of the potential electrical hazard when working inside the gantry of these specific CT systems. The source text does not provide specific consumer instructions or corrective actions beyond the identification of the hazard.

The recalled product

Product
GE Healthcare Optima CT660. Sold under the following product names: BEIJING OPTIMA CT660 PRO GT170, BEIJING OPTIMA CT660 PRO GT200, BEIJING OPTIMA CT660S PRO 32 S, CT GOLDSEAL, CT GOLDSEAL OPTIMA 660, CT GOLDSEAL OPTIMA 660 UT-BUC, CT OPTIMA 660 LNG HN P20, CT OPTIMA 66
Manufacturer
GE Healthcare Japan Corporation
Category
Medical Device — CT Scanner
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): 5454001-220
  • 00000296364HM3 (910212220)
  • 5454001-222
  • 00000316775HM6 (910216062)
  • 00000316560HM2 (GF1001CT02)
  • 00000312787HM5 (190163CT01)
  • 5454001-200
  • 00000296053HM2 (M2842586)
  • 00000312788HM3 (M9024415)
  • 5454001-220
  • 00000302025HM2 (M4189263)
  • 00000316776HM4 (600118CT01)
  • 00000305880HM7 (X140985807)
  • 5454001-100
  • 427331CN4 (412357CT)
  • 424963CN7 (334826CT)
  • 373759GE0 (303LA660CT)
  • 428253CN9 (SHICT01432)
  • 5454001-22

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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