RecallHawk
Class II Recall

Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including

GE Medical Systems, LLC

Summary

The FDA issued a Class II for Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device by GE Medical Systems, LLC. Reason: There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on t.

Details

Source

Device Recall

External ID

Z-1569-2026

Action Date

2026-03-25

Status

Ongoing

Category

device

Product Description

Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 5826659-027, 5826659-029, 5826659-032, 5826659-033, 5826659-028, 5826659-034, 5826659-030, 5826659-019, 5826659-022, 5826659-026, 5826659-023, 5826659-031, 5826659-025, 5826659-002, 5826659-021, 5826659-037, 5826659-014, 5826659-016, 5826659-013

Lot/Code Info: UDI Numbers: (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1035825832001 (01)00840682145794(10)70P1035825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1035825832001 (01)00840682145794(10)70P004105825832001 (01)00840682145794(10)70P1035825832001 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(01)00840682145794(10)70P1025825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)00840682145794(10)70P1015825832001 (01)008406821

Quantity Affected: 1568 units

Reason for Recall

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.

Distribution

Worldwide - US Nationwide distribution.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-01-30

Company

GE Medical Systems, LLC

Waukesha, WI

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 156 device recalls issued in the same week, part of 403 device-related FDA actions this month.

GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Medical Systems, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does GE Medical Systems, LLC have FDA actions?

GE Medical Systems, LLC has 138 FDA actions in our database, including 121 recalls and 17 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1569-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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