The Recall Desk
HighFDA (Devices)·Z-1130-2021·Announced 2021-02-24

GE Healthcare Recalls Revolution CT Systems Due to Table Pinch Protector Defect

GE Healthcare is recalling Revolution CT and Revolution CT ES systems because damaged or missing table pinch protectors may expose sharp screws, posing a laceration risk.

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 (sharp edges causing laceration) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

GE Healthcare, LLC is recalling 1,115 units of Revolution CT, Revolution CT ES, Revolution Apex, and Revolution CT with Apex Edition systems. The recall is due to a potential issue where the table pinch protector could be damaged or missing.

This defect may lead to exposed table screws with sharp edges, which could cause a laceration. The affected units were distributed nationwide in the United States and in numerous countries worldwide, including Australia, Canada, China, Germany, and the United Kingdom.

The source text does not specify specific actions for consumers or healthcare facilities beyond the recall notice. Users of these systems should contact GE Healthcare for further instructions regarding the repair or replacement of the table pinch protectors.

The recalled product

Product
System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
Manufacturer
GE Healthcare, LLC
Category
Medical Device — CT Scanner
Hazard
Affected units
1,115

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 Numbers: 5590000: 00000441224CN3
  • 00000441064CN3
  • 00000442592CN2
  • 00000396676HP9
  • 00000442124CN4
  • 00000439287CN4
  • 00000439205CN6
  • 00000439823CN6
  • 00000445059CN9
  • 00000442706CN8
  • 00000444409CN7
  • 00000437624CN0
  • 00000443069CN0
  • 00000444745CN4
  • 00000441716CN8
  • 00000441624CN4
  • 00000441575CN8
  • 00000445084CN7
  • 00000444165CN5
  • 00000444872CN6

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 2 recalled by GE Healthcare, 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 2 products in this recall →

Related recalls

Same manufacturer · GE Healthcare, LLC

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Same hazard · laceration

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