Recall Z-1300-2025— GE Medical Systems, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2025-02-18. It names 2 FDA 510(k) clearances: K213715, K191777. Product: GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed. Reason: 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..
- Recalling firm
- GE Medical Systems, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-18
- Firm location
- Waukesha, WI, United States
510(k) clearances named in this recall
2 on FDA's record- K213715 — Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT +3 more
- K191777 — Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.