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

Recall Z-2252-2014 — Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.

U.S. FDA — Device Enforcement · United States · 2014-07-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2252-2014
Date of alert
2014-07-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Philips Healthcare Informatics, Inc.
Product category
device
Product type
Devices
Reported risk: A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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