Fresh Recalls

FDAClass II · Medical device · Recall Z-2154-2026 · Recalled May 20, 2026

Revolution Apex recall — GE Medical Systems, LLC

Agency report date: May 20, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Revolution Apex
Company / brand
GE Medical Systems
Lot / serial / date codes
UDI-DI: 00840682146616; Serial Numbers: REV2A2200014CN REV2A2200072CN REV2A2100016CN REV2A2200068CN REV2A2200034CN REV2A2200116CN REV2A2200037CN REV2A2000006CN REV2A2200041CN REV2A2100011CN REV2A2100048CN REV2A2200015CN REV2A2100038CN REV2A2200011CN REV242200002CN REV2A2200120CN REV2A2200018CN REV2A2300016CN REV2A2200067CN REV2A2000007CN REV2A2200105CN REV2A2200007CN REV2A2000032CN REV2A2100019CN
Distribution
Worldwide - US Nationwide distribution.
Agency product description and boundaries

Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Revolution Apex recall status

3. Open the official notice or contact

Official recall ID
Z-2154-2026
Brand
All GE Medical Systems recalls
Classification
Class II
Units affected
24 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Waukesha, WI, United States
Firm address
3000 N Grandview Blvd, 53188-1615

Identifying details (verbatim from the notice)

Product codes / lots
UDI-DI: 00840682146616; Serial Numbers: REV2A2200014CN REV2A2200072CN REV2A2100016CN REV2A2200068CN REV2A2200034CN REV2A2200116CN REV2A2200037CN REV2A2000006CN REV2A2200041CN REV2A2100011CN REV2A2100048CN REV2A2200015CN REV2A2100038CN REV2A2200011CN REV242200002CN REV2A2200120CN REV2A2200018CN REV2A2300016CN REV2A2200067CN REV2A2000007CN REV2A2200105CN REV2A2200007CN REV2A2000032CN REV2A2100019CN
Distribution
Worldwide - US Nationwide distribution.
Firm notified the public via
Letter
FDA event ID
98738
Recall initiated
March 26, 2026
FDA classified
May 8, 2026
FDA report date
May 20, 2026

Other medical device recalls from around the same time

Verify with the official sources:

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved August 18, 2026 at 6:00 PM UTC.

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