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

Recall Z-0225-2014 — Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display image

U.S. FDA — Device Enforcement · United States · 2013-09-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0225-2014
Date of alert: 2013-09-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Carestream Health Inc.
Product category: device
Product type: Devices

Reported risk: Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a software problem.

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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