Revolution CTRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

6 FDA recall records name this device's identifier, 6 still open.

17 other recalls cover devices cleared under the same FDA submission (K093581, K133705); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 26, 2026Open, Classified

   GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

   Z-2150-2026 · Root cause: Software design · FDA record ↗

2. Feb 18, 2025Open, Classified

   GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

   Z-1303-2025 · Root cause: Process change control · FDA record ↗

3. Feb 18, 2025Open, Classified

   GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

   Z-1299-2025 · Root cause: Process change control · FDA record ↗

4. Feb 18, 2025Open, Classified

   GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

   Z-1297-2025 · Root cause: Process change control · FDA record ↗

5. Feb 18, 2025Open, Classified

   GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

   Z-1302-2025 · Root cause: Process change control · FDA record ↗

6. Feb 18, 2025Open, Classified

   GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

   Z-1300-2025 · Root cause: Process change control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093581, K133705. One submission often covers many models, so check the product and lot details in each record.

• Z-0613-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/comput
• Z-0600-2025 · Nov 5, 2024 · Open, Classified
  GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
• Z-0242-2022 · Jun 30, 2021 · Open, Classified
  Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
• Z-2021-2021 · Jun 30, 2021 · Open, Classified
  The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different a
• Z-0816-2022 · Jun 30, 2021 · Open, Classified
  Revolution CT, Revolution CT ES
• Z-2004-2021 · Mar 19, 2021 · Completed
  Revolution CT
• Z-1130-2021 · Dec 17, 2020 · Terminated
  System, X-Ray, Tomography, Computed: Revolution CT, Revolution CT ES.
• Z-1951-2019 · Jan 19, 2019 · Open, Classified
  Revolution CT scanners Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
• Z-0776-2019 · Jul 12, 2018 · Open, Classified
  Revolution CT systems with the SmartStep Option The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
• Z-2582-2018 · May 24, 2018 · Terminated
  Revolution CT 160 1.5D STD WAUK
• Z-2184-2017 · May 19, 2017 · Terminated
  GE Healthcare Optima CT580; Discovery RT, CT590 RT X-ray system
• Z-1915-2016 · May 9, 2016 · Terminated
  GE Revolution CT The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images
• Z-1589-2016 · Apr 20, 2016 · Terminated
  GE, Revolution CT. The system is intended for head, whole body, cardiac, and vascular X-ray Computed Tomography applications
• Z-0401-2016 · Oct 23, 2015 · Terminated
  GE Healthcare, Revolution CT Scanners. Revolution CT- The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is inte
• Z-0985-2015 · Dec 19, 2014 · Terminated
  GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.

…and 2 more.