medical Class II Updated 2021-12-01

GE Healthcare, LLC recalls Computed Tomography Systems Revolution CT, Revolution CT

Recalled Product

Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition

Hazard / Issue

The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
View official government recall

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