GE Healthcare Centricity Universal Viewer Recall for Report Display Issue
GE Healthcare is recalling 803 units of the Centricity Universal Viewer Zero Footprint Client because the latest addended report may not display by default in specific browsers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity. The hazard is a software display error that may lead to users missing addended reports, but no injuries or illnesses are reported in the source text.
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…
- Manufacturer
- GE Healthcare
- 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.
Lot numbers (20)
- UDI/DI: 00840682102988: a) 2110344-008
- KMCH-Centricity Universal Viewer Zero Footprint / ZFP-01819848
- 355920-Centricity Universal Viewer Zero Footprint / ZFP-20996307
- 225717-Centricity Universal Viewer Zero Footprint / ZFP-19666806
- RF0827-Centricity Universal Viewer Zero Footprint / ZFP-19460712
- b) 2110344-009
- 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348000
- 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348009
- 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348010
- 1495-3-Centricity Universal Viewer Zero Footprint / ZFP-02348035
- 1407636-Centricity Universal Viewer Zero Footprint / ZFP-19632983
- SA1008-Centricity Universal Viewer Zero Footprint / ZFP-20620864
- c) 2110344-010
- 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-00098228
- 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-14194760
- 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023936
- 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023938
- 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023939
- 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023940
- 3922-18-Centricity Universal Viewer Zero Footprint / ZFP-16023941
Distribution
Distribution scope not specified by the agency.
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