FDAClass II · Medical device · Recall Z-2150-2026 · Recalled May 20, 2026

Revolution CT 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 CT
Company / brand: GE Medical Systems
Lot / serial / date codes: UDI-DI: 00840682118552; Serial Numbers:REVVX2300007CN 443327CN2 REVVX1600034CN REVVX2400004CN REVVX2200047CN 441716CN8 00000440713CN6 REVVX1800043CN 441839CN8 REVVX1700067CN REVVX1800007CN REVVX1800105CN REVVX1800048CN REVVX1900123CN REVVX1800046CN REVVX2000005CN REVVX2200009CN REVVX1600013CN REVVX1700101CN REVVX2200025CN REVVX2100028CN REVVX1900069CN REVVX2100020CN REVVX2100014CN REVVX2100050CN REVVX1600052CN 438902CN9 REVVX1900107CN 438369CN1 REVVX1900018CN REVVX1700071CN REVVX1700082CN 442792CN8 REVVX2200007CN REVVX1700104CN REVVX2000056CN REVVX1900086CN REVVX2200039CN
Distribution: Worldwide - US Nationwide distribution.

Agency product description and boundaries

Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

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 CT recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2150-2026
Brand: All GE Medical Systems recalls
Classification: Class II
Units affected: 38 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Revolution CT recall status

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: 00840682118552; Serial Numbers:REVVX2300007CN 443327CN2 REVVX1600034CN REVVX2400004CN REVVX2200047CN 441716CN8 00000440713CN6 REVVX1800043CN 441839CN8 REVVX1700067CN REVVX1800007CN REVVX1800105CN REVVX1800048CN REVVX1900123CN REVVX1800046CN REVVX2000005CN REVVX2200009CN REVVX1600013CN REVVX1700101CN REVVX2200025CN REVVX2100028CN REVVX1900069CN REVVX2100020CN REVVX2100014CN REVVX2100050CN REVVX1600052CN 438902CN9 REVVX1900107CN 438369CN1 REVVX1900018CN REVVX1700071CN REVVX1700082CN 442792CN8 REVVX2200007CN REVVX1700104CN REVVX2000056CN REVVX1900086CN REVVX2200039CN
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

Automated Impella Controller (AIC) recall — Abiomed, Inc.FDA · June 3, 2026
RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers recall — Bolton Medical Inc.FDA · June 3, 2026
NextStep Antegrade Chronic Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026
Cannon II Plus Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter recall — ARROW INTERNATIONAL, LLCFDA · May 20, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

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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