Z-2252-2014Class II

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

Name: Z-2252-2014 Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and...
Creator: Philips Healthcare Informatics, Inc.
Published: 2014-07-24
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2014-07-24 / Terminated / root cause: software

FDA source

Philips Healthcare Informatics, Inc. began a recall of Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage on 2014-07-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2252-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-24
Posted: 2014-08-16
Terminated: 2016-02-11
Recalling firm: Philips North America LLC
Product: Philips IntelliSpace PACS 4.4 image management systems performs digital image processing, measurement and communication and storage.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction was sent to all affected sites on July 24, 2014 by certified mail.
Quantity in commerce: 109 units
Distribution: US and Australia, Belgium, Canada, Egypt, France, Germany, Netherlands, Oman, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
Product codes and lots: IntelliSpace 4.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2252-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2252-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-15

Product code LLZ

K111804Class IIIntellispace Pacs 4.XPhilips Healthcare Informatics, Inc. / cleared 2011-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)