The Recall Desk
HighFDA (Devices)·Z-0816-2022·Announced 2022-04-13

CT Scanner Dose Display Shows Inaccurate Values in Certain Situations

GE Healthcare Revolution CT scanners display inaccurate radiation dose values in certain situations. This could affect clinical dosing decisions during patient scans.

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: This is classified as FDA Class II and constitutes a risk-of-harm scenario through inaccurate dose reporting on a radiation imaging device. No patient illnesses or injuries have been reported, but display errors affecting critical radiation dose information meet the High severity criterion.

Plain-English summary

GE Healthcare has recalled Revolution CT and Revolution CT ES computed tomography (CT) imaging systems due to an error in dose reporting. In certain situations, the accumulated dose is displayed inaccurately, with the SmartStep feature displaying values that are higher than correct.

A total of 273 systems have been distributed globally, including 51 in the United States and 222 outside the US. Inaccurate dose display could affect clinical decisions regarding radiation exposure during CT examinations.

Healthcare facilities operating these systems should contact GE Healthcare for guidance on identifying and addressing affected units. Clinical staff should be aware of this display error when interpreting dose information from affected devices.

The recalled product

Product
Revolution CT, Revolution CT ES
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging
Hazard
  • dose-display-error

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 (2)

  • Revolution CT
  • Revolution CT ES

Distribution

Distributed nationwide across the United States.

Related recalls

Same category