The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2870-2018·Announced 2018-08-29

GE Healthcare Recalls CT Systems Due to Damaged Cable Electrical Hazard

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

GE Healthcare Japan Corporation is recalling certain CT systems, including the Revolution EVO, Optima CT660, Optima CT670, and Optima CT680 models. The recall involves 4,007 devices distributed worldwide, including across the United States and numerous international countries.

The recall was initiated because GE Healthcare identified that some of these systems may have a damaged cable. This defect can expose 120VAC electrical current to Service Engineers who are working inside the gantry of the machine.

The affected devices are intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. Service engineers should be aware of the potential electrical exposure risk when performing maintenance or repairs inside the gantry area.

The recalled product

Product
GE Healthcare Revolution EVO, Optima CT660, Optima CT670, Optima CT680. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold under the following product names: CT GOLDSEAL LIGHTSPEED ULTRA, CT OPTIMA 660, CT OPTIMA…
Manufacturer
GE Healthcare Japan Corporation
Category
Medical Device — Computed Tomography (CT) Systems
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): 5454001-260
  • CBCGG1600028HM (817261ULTRA)
  • 5454001-240
  • 00000389996HM0 (83021861077017)
  • 5454001-40
  • 00000074499YC5 (850210882)
  • 00000075588YC4 (850210905)
  • 00000069668YC2 (850210888)
  • 00000075080YC2 (850210904)
  • 00000071456YC8 (850210894)
  • 00000077687YC2 (850210910)
  • 00000073633YC0 (850210902)
  • 00000073638YC9 (850210900)
  • 40GAN1600013YC (850210908)
  • 00000424383HM8 (HU1113CT01)
  • 00000391751HM5 (DPN26338)
  • 00000387390HM8 (UE535A128)
  • 00000394185HM3 (NEV44709)
  • 00000394592HM0 (NEV44708)

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 →

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