GE Healthcare, LLC Revolution Apex, Revolution CT with Apex Edition Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Revolution Apex, Revolution CT with Apex Edition
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
Revolution Apex, Revolution CT with Apex Edition
Products Sold
Revolution Apex, Revolution CT with Apex Edition
GE Healthcare, LLC is recalling Revolution Apex, Revolution CT with Apex Edition due to The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being i. 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. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
Recommended Action
Per FDA guidance
GE Healthcare sent an Important Electronic Product Radiation Warning letter dated February 8, 2022 to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take. 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 Services at 1 (800) 437-1171 or 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