GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
Summary
The FDA issued a Class II for GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed by GE Medical Systems, LLC. Reason: GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product detail.
Details
Source
Device Recall
External ID
Z-1300-2025
Action Date
2025-03-19
Status
Ongoing
Category
device
Product Description
GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
Lot/Code Info: System ID Number 907729APEX1, UDI (01)00195278460271(11)231100(21)REV2X2300082CN, Mfg. Lot/Serial Number REV2X2300082CN; System ID Number 336832APEX, UDI (01)00195278460271(11)241000(21)REV2X2400129CN, Mfg. Lot/Serial Number REV2X2400129CN; System ID Number 973971CTREV, UDI (01)00840682118552(11)160600(21)REVVX1600010CN, Mfg. Lot/Serial Number REVVX1600010CN; System ID Number 513584APEX1, UDI (01)00840682146616(11)230300(21)REV2A2300023CN, Mfg. Lot/Serial Number REV2A2300023CN
Quantity Affected: 4 units
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.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-18
Company
Waukesha, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 159 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Medical Systems, LLC have FDA actions?
GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1300-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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