Class II U.S. Food and Drug Administration

GE Medical Systems, LLC Revolution Apex, 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-2154-2026
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
24 units
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
00840682146616

Products covered by this recall

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

Check your product

The notice names 3 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.

  • 00840682146616

Model or item number

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

  • 5590000-20 — UDI-DI

Serial number

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

  • REV2A2200014CN REV2A2200072CN REV2A210001

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. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

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 00840682146616; model number 5590000-20 — 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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