Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0454-2014 — The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare practitioner. The Centricity Enterprise Web is an image and information distribution system for the clinical review of medical images and reports. The Centricity Enterprise Web is

U.S. FDA — Device Enforcement · United States · 2012-04-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0454-2014
Date of alert: 2012-04-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ge Healthcare It
Product category: device
Product type: Devices

Reported risk: GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient safety. The WADO (Web Access to DICOM Objects) interface allows for embedding DICOM images as JPEGs on a web page and is available as a licensed operation on Centricity Web. When rejected images are archived by Centricity PACS to Enterprise Archive, an

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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