Z-1125-2012

Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic...

Name: Z-1125-2012 Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic...
Creator: Philips Medical Systems Nederlands
Published: 2012-01-27
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2012-01-27 / Terminated / root cause: software

FDA source

Philips Medical Systems Nederlands began a recall of Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a... on 2012-01-27. The reason FDA records is "There maybe incorrect values in the diffusion/perfusion maps". 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-1125-2012
Status: Terminated
Initiated: 2012-01-27
Posted: 2012-02-29
Terminated: 2021-02-25
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Philips Intellispace Portal, Release 4.0.0. For storing, processing and management of electronic information/data Model: 881001. Indicated for use as a diagnostic device.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: There maybe incorrect values in the diffusion/perfusion maps.
Root cause tag: software
FDA root cause: Software design
Action: Philips issued URGENT - Medical Device Correction Notifications, dated January 20, 2012. The letter identified the affected product, all Intellispace Portal with software release 4.0.0 Installed, and gave a description of the problem. Users were provided with the actions to be taken prior to the software upgrade( to version 4.0.1). Users are to follow the instructions provided in order to generate maps with the correct values and to make sure that the setting is correct before using the generated data. Philips will contact customers in order to install the update free of charge. Customers should contact their local Philips representative at 866-767-2822
Quantity in commerce: 25 units
Distribution: Worldwide Distribution -- US, including states of IN and TX, and countries of Australia, Austria, Czech, Denmark, France, Germany, Indonesia, Netherlands, Poland, Spain, and Switzerland.
Product codes and lots: Software release 4.0.0

Product code LNH

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)