Class II U.S. Food and Drug Administration

GE Medical Systems, LLC Centricity Universal Viewer Software Versions 5.0 SP6 through recall: There is a potential cybersecurity vulnerability affecting certain versions

Recall published 7 months ago

There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

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-1571-2026
Published
March 25, 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
40 units
Distribution
Nationwide
Made in
United States
Lot / code info
Product ID Numbers: 4446-2-Centricity Universal Viewer-00558643 100256-3-Centricity Universal Viewer-00558700 101044-1-Centricity Universal Viewer-00558694 13240-2-Centricity Universal Viewer-00558103 4441-1-Centricity Universal Viewer-00558677 4578-1-Centricity Universal Viewer-00558340 10831-2-Centricity Universal Viewer-00558682 656341-Centricity Universal Viewer-01431499 50567-Centricity Universal Viewer-02176369 2690973-Centricity Universal Viewer-01454622 EG1526-Centricity Universal Viewer-00158976 A91901-Centricity Universal Viewer-00044549 M3488569-Centricity Universal Viewer-00071707 25540620 - HC4105-Centricity Universal Viewer-00001393 416005-Centricity Universal Viewer-00260808 1868708X - 556162-Centricity Universal Viewer-00157857 HKOB01-Centricity Universal Viewer-01282268 BMH-Centricity Universal Viewer-01820534 JIPMER-Centricity Universal Viewer-01820555 4347967-Centricity Universal Viewer-01474540 651342-Centricity Universal Viewer-01365218 651342-Centricity Universal Viewer-01365213 A3431341-Centricity Universal Viewer-00545677 473265-Centricity Universal Viewer-01442014 JP-131575-Centricity Universal Viewer-01275307 442900-Centricity Universal Viewer-01460668 577127-Centricity Universal Viewer-01444349 349551-Centricity Universal Viewer-02350518 PL3277-Centricity Universal Viewer-00038831 RU3866-Centricity Universal Viewer-01445731 RU8945-Centricity Universal Viewer-01445740 RU2580-Centricity Universal Viewer-01445743 1354732-Centricity Universal Viewer-01273292 RU3453-Centricity Universal Viewer-01273249 SA2160-Centricity Universal Viewer-00111827 SA1208-Centricity Universal Viewer-00066587 882983-Centricity Universal Viewer-02277629 ZA2533-Centricity Universal Viewer-00116577

Products covered by this recall

Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150

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.

Model or item number

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

  • 2088026-026
  • 2088026-115
  • 2088026-043
  • K2042VJED

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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?

There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number 2088026-026, 2088026-115, 2088026-043. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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