GE Healthcare Centricity Universal Viewer Recall for Report Display Issue

Plain-English summary

GE Healthcare is recalling 803 units of the Centricity Universal Viewer Zero Footprint Client (ZFP), a radiological image processing system. The affected model numbers include 2110344-008, 2110344-009, 2110344-010, 2110344-011, 2110344-013, 2110344-019, 2110344-025, 2110344-029, 2110344-030, and 2110344-032. The units were distributed worldwide.

The recall is due to a software issue in ZFP versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. This issue occurs specifically when the addendum is created on the same day as the original report but at a different time, and only when the system is launched on Internet Explorer 10, Internet Explorer 11, or Firefox.

Healthcare facilities using these systems should verify their software versions and browser configurations. Users should ensure that addended reports are manually checked or that the software is updated to a version that resolves this display default.

The recalled product

Product

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological i

Manufacturer

GE Healthcare

Category

Medical Device — Radiological Image Processing

Hazard

• software-defect
• data-display-error

Affected units

803

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distribution scope not specified by the agency.

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