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

Recall Z-1886-2019 — Centricity Universal Viewer with PACS-IW foundation 6.0, Model number 2090255-001 Product Usage: Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed

U.S. FDA — Device Enforcement · United States · 2019-05-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1886-2019
Date of alert: 2019-05-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00558570

Reported risk: There is a potential that one or more images or image series may be missing from exams without a warning displayed in the viewer.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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