The Recall Desk
HighFDA (Devices)·Z-0815-2022·Announced 2022-04-13

CT Scanner Dose Display Error in GE Healthcare Revolution Systems

GE Healthcare Revolution Apex and Revolution CT systems display accumulated radiation doses inaccurately high in certain situations. No injuries have been reported.

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 an FDA Class II medical device with a confirmed functional defect affecting radiation dose display and monitoring. No illnesses or injuries have been reported. As a risk-of-harm product without yet-reported injury, this warrants a High severity classification.

Plain-English summary

GE Healthcare, LLC has recalled its Revolution Apex and Revolution CT with Apex Edition systems due to a defect in how accumulated dose is displayed. The SmartStep feature displays the accumulated dose inaccurately high in certain situations.

These CT imaging systems are used in healthcare facilities to perform diagnostic scans. An inaccurate dose display could affect clinical monitoring and decision-making regarding radiation exposure.

Approximately 273 units are affected worldwide, including 51 in the United States and 222 units outside the United States. Healthcare providers currently using affected systems should contact GE Healthcare, LLC or the Food and Drug Administration for remediation guidance.

The recalled product

Product
Revolution Apex, Revolution CT with Apex Edition
Manufacturer
GE Healthcare, LLC
Category
Medical Device — Diagnostic Imaging / CT Scanner
Hazard
  • dose-display-error
  • radiation-overdose-risk

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 Apex
  • Revolution CT with Apex Edition

Distribution

Distributed nationwide across the United States.

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