Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Philips IntelliSpace PACS 4.4 image management systems performs digital image Recalled by Philips Healthcare Informatics, Inc. Due to A problem was detected in the Philips IntelliSpace...

Date: July 24, 2014
Company: Philips Healthcare Informatics, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Philips Healthcare Informatics, Inc. directly.

Affected Products

Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.

Quantity: 109 units

Why Was This Recalled?

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.

Where Was This Sold?

US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.

About Philips Healthcare Informatics, Inc.

Philips Healthcare Informatics, Inc. has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report