Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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 image processing system

FDA Recall Z-3160-2024 · Posted 2024-09-17

Recalling FirmGE Healthcare
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2024-07-23
Product Quantity803 units

Reason for Recall

Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user. The issue occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers. " Internet Explorer 10 (IE10) " Internet Explorer 11 (IE11) " Firefox.

Firm Action

GE Healthcare issued an URGENT MEDICAL DEVICE CORRECITON notice to its consignees on 07/23/2023 via letter. The notice explained the issue, potential risk to the patient, and provided the following actions be taken: "You can continue to use your device. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions below. Follow one of the below recommendations to ensure the latest addendum is being reviewed: 1. Use Microsoft Edge or Google Chrome browsers when launching ZFP Viewer. OR 2. If you cannot use the browsers listed in #1, to find the addendum / latest report, review all the reports available for the study in the Series Selector. Navigation to the series selection can be found in the User Manual under Section 2.3.3 of The Series Selector, with subheading as Open a report/document using series selector"." GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. For questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Root Cause

Software Design Change

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑