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

The 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 and displayed within the system or across computer networks at distributed locations. Typical use — recall Z-0225-2016

U.S. FDA — Device Enforcement · United States · 2015-09-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0225-2016
Date of alert: 2015-09-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare
Product category: device
Product type: Devices

Reported risk: Inaccurate distance measurements with magnified projection X-ray images.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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