FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- Recall number
- Z-0242-2022
- Recalling firm
- GE Healthcare, LLC
- Product
- Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- Status
- Open, Classified
- Initiated
- 2021-06-30
- Posted
- 2021-11-24
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Action
- 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.
- Quantity
- 105 in total
- Distribution
- Worldwide and US Nationwide Distribution
- Lot, serial or model codes
- Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
- 510(k) numbers
- ["K133705","K163213","K191777"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28