Class II U.S. Food and Drug Administration

GE Medical Systems, LLC Revolution CT, x-ray computed tomography recall: GE HealthCare has become aware of a potential security vulnerability

Recall published 5 months ago

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.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2150-2026
Published
May 20, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
GE Medical Systems, LLC
Product type
Medical devices
Units affected
38 units
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
00840682118552

Products covered by this recall

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

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00840682118552

Model or item number

On the rating label, the box or the instruction sheet.

  • 5590000
  • 5590000-6 — UDI-DI

Serial number

On the rating plate, often next to the date of manufacture.

  • REVVX2300007CN 443327CN2 REVVX1600034CN R

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

GE Medical Systems, LLC — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: GE Medical Systems, LLC — 3000 N Grandview Blvd, Waukesha, WI, 53188-1615

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was GE Medical Systems, LLC medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00840682118552; model number 5590000, 5590000-6 — UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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