GE Healthcare, LLC Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
Products Sold
Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
GE Healthcare, LLC is recalling Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with due to The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
GE sent an Important Electronic Product Radiation Warning Notification letter dated October 4, 2021 to customers, The letter identified the affected product, problem and actions to be taken. Customers were informed that GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026