Z-2000-2012Class II

Intellispace Portal software

Name: Z-2000-2012 Intellispace Portal software
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-05-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-05-22 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and... on 2012-05-22. FDA classified it as Class II and gives the reason as "In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode "edit contour" tool, the measurements are not recalculated causing discrepancies with the lesion...". 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-2000-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-22
Posted: 2012-07-12
Terminated: 2013-03-28
Recalling firm: Philips North America LLC
Product: Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from compatible computers on a network.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode "edit contour" tool, the measurements are not recalculated causing discrepancies with the lesion measurements.
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent an Urgent-Medical Device Correction letter dated May 23, 2012, via certified mail to each consignee. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. The letter informed affected customers that a Philips Service Engineer will contact them for implementation of the software update on the affected systems free of charge. For any further information or support, customers can contact their local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).
Quantity in commerce: 44
Distribution: Worldwide Distribution - US (nationwide) including the states of: AR, LA, MI, NC, NY, OH, OK and PA and the countries of: Australia, Canada, Denmark, France, Germany, Israel, Netherlands, Spain and Switzerland.
Product codes and lots: Model number: 881001; serial numbers: 80818, 85088, 81178, 82006, 82038, 81063, 82018, 79935, 81150, 81013, 81173, 85068, 79932, 79943, 80911, 82019, 81027, 85049, 85043, 82008, 81119, 81089, 85108, 85026, 85146, 80994, 81021, 81182, 81017, 85067, 81161, 81164, 79936, 85103, 81147, 85110, 85082, 81179, 81035, 85046, 81031, 81129, 81004 & 85104.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2000-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2000-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-11

Product code JAK

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)