Z-0269-2014Class II

Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with...

Name: Z-0269-2014 Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with...
Creator: Philips Healthcare Informatics, Inc.
Published: 2013-10-14
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-10-14 / Terminated / root cause: software

FDA source

Philips Healthcare Informatics, Inc. began a recall of Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store... on 2013-10-14. FDA classified it as Class II and gives the reason as "Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device does not store additional images...". 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-0269-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-14
Posted: 2013-11-13
Terminated: 2014-06-11
Recalling firm: Philips North America LLC
Product: Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare Informatics, Inc. Foster City, CA IntelliSpace PACS are image management systems intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RE, RT, MG, SC, VL, as well as hospital/radiology information systems.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that a timing issue has been identified that may result in a condition where the device does not store additional images received before processing is complete. The missing images may contain pathology which may result in a different diagnosis if they had been available at time of interpretation.
Root cause tag: software
FDA root cause: Software in the Use Environment
Action: Philips sent an Urgent Field Safety Notice dated October 14, 2013, to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please review the following with all radiology technicians who use lntelliSpace BY CUSTOMER/USER PACS: " Assure you and your colleagues are aware of the problem. " Verify that all images sent for each study are present on the iVault before the images are purged from the modality. o Use the image count from the lower right corner of the thumbnails as seen in Enterprise only. Single images (such as CR, DX and MG) show no image count, so the user should count those thumbnails without image counts as one. Add all the numbers up to come up with the total number of viewable images, stored to lntelliSpace. " Compare number of images sent from the modality and those sent from other 3rd party source to image count in IntelliSpace PACS. " If the image count on the modality or 3 party source indicates there are more images to the study than are present on the iVault, the study should be resent from the modality and/or 3 party source. " Resending the studies will typically correct the problem but the technician should again verify the image count is correct. If you need any further information or support concerning this issue, please INFORMATION AND contact your Philips representative or contact Care at [email protected]. Please call (650) 293-2300 for further questions.
Quantity in commerce: 71 units
Distribution: Worldwide Distribution - USA (nationwide) and country: Canada.
Product codes and lots: All units of these IntelliSpace PACS.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0269-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0269-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-20	2013-11-13

Product code LLZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)