The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2873-2018·Announced 2018-08-29

GE Healthcare Optima CT660 Systems Recalled for Damaged Cable Hazard

GE Healthcare is recalling Optima CT660 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 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 CT660 systems. These systems are intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications. The recall involves 92 units distributed outside the United States.

The recall was initiated because GE Healthcare identified that some of these CT systems may have a damaged cable. This defect can expose 120VAC to service engineers working inside the gantry. The source text does not report any injuries or illnesses associated with this defect.

Affected units are identified by specific model and serial numbers listed in the official recall documentation. The systems were sold under various product names, including CT OPTIMA 660 and OPTIMA CT660, in numerous countries worldwide. Service engineers should verify the serial numbers of the systems they are servicing against the official list to determine if a unit is affected.

The recalled product

Product
GE Healthcare Optima CT660. The systems are intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. Sold only outside the U.S. under the following product names: CT OPTIMA 660, CT OPTIMA 660 LONG BJG SKD RUS, CT OPTIMA 660 LONG BJG SKD…
Manufacturer
GE Healthcare Japan Corporation
Category
Medical Device — Computed Tomography (CT) Scanner
Hazard
Affected units
92

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): 6375965-146
  • CJRSX1600007CN (CJRSX1600007CN)
  • 6375965-146
  • CJRSX1600001CN (CJRSX1600001CN)
  • 6375965-100
  • 00000433543CN6 (CT433543CN6)
  • 00000438341CN0 (CT438341CN0)
  • CJRSX1600003CN (CJRSX1600003CN)
  • CJRSX1600004CN (CJRSX1600004CN)
  • CJRSX1700005CN (CJRSX1700005CN)
  • CJRSX1700009CN (CJRSX1700009CN)
  • 00000432220CN2 (CT432220CN2)
  • 00000438956CN5 (CT438956CN5)
  • CJRSX1700012CN (CJRSX1700012CN)
  • 00000438278CN4 (CT438278CN4)
  • 00000439130CN6 (CT439130CN6)
  • CJRSX1700003CN (CJRSX1700003CN)
  • 00000433540CN2 (CT433540CN2)
  • 00000440700CN3 (CT440700CN3)

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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