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

Recall Z-1495-2014 — Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). The MDC PACS/IntelliSpace PACS DCX is a s

U.S. FDA — Device Enforcement · United States · 2014-04-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1495-2014
Date of alert: 2014-04-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: Philips MDC PACS Release R2.x and Philips IntelliSpace PACS DCX R3.x, may have incorrect density measurement on Enhanced CT/MR examinations

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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