Z-1988-2012Class II

Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that...

Name: Z-1988-2012 Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-05-23
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-05-23 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical... on 2012-05-23. FDA classified it as Class II and gives the reason as "Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of "PAC Integration"...". 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-1988-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-23
Posted: 2012-07-11
Terminated: 2013-03-28
Recalling firm: Philips North America LLC
Product: Intellispace Portal software. Intellispace Portal is a multimodality thin client applications server that delivers full diagnostic viewing and clinical applications to the enterprise.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Philips is issuing a software update to the Intellispace Portal systems to address a number of non-conformances. The most frequent and severe non-conformance identified involves the portal setting of "PAC Integration". This setting has a feature that allows the user to launch images of multiple patient studies into an application, but does not display a warning message informing the user that diff
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated May 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact your local Philips representative or the Customer Care Solutions Center at 1-800-722-9377, option 5, for questions regarding this recall.
Quantity in commerce: 96
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, FL, GA, IA, IN, MI, NC, NJ, NY, OK, PA, SC, TN, TX, and WA and the countries of Australia, Austria, Canada, China, Czech Republic, Denmark, and France.
Product codes and lots: Model number 881001; Serial numbers: 81172, 79937, 85083, 81097, 85145, 79916, 81132, 85011, 82020, 85007, 85006, 85081, 81028, 80914, 82004, 85041, 81180, 82016, 30019, 80910, 81133, 81098, 81169, 79940, 80980, 82036, 82007, 85084, 85085, 82039, 81127, 81165, 30003, 80818, 30007, 85042, 81184, 82021, 82030, 82023, 82051, 82026, 82024, 82028, 82050, 82025, 82029, 82027, 30018, 79933, 82015, 85089, 30036, 81183, 82037, 80425, 81157, 85025, 82011, 81174, 80965, 80966, 81026, 35006, 82009, 81013, 82003 & 80891.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1988-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1988-2012	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)