Z-1337-2012

IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin- client...

Name: Z-1337-2012 IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin- client...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-02-22
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-02-22 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin- client applications server that delivers full diagnostic... on 2012-02-22. The reason FDA records is "A number of non-conformances were logged for IntelliSpace Portal running software version 4.0 during in-house random verification testing. When loading a study to Review, after failing to load it through Add to Running...". 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-1337-2012
Status: Terminated
Initiated: 2012-02-22
Posted: 2012-03-30
Terminated: 2013-02-22
Recalling firm: Philips North America LLC
Product: IntelliSpace Portal, M/N 881001, IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin- client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: A number of non-conformances were logged for IntelliSpace Portal running software version 4.0 during in-house random verification testing. When loading a study to Review, after failing to load it through Add to Running Application the Analysis application is not being closed and different (1st loaded study) patient appears in analysis (CCA).
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent an Urgent Medical Device Correction letter dated February 23, 2012, to all affected customers. 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. Customers were asked to retain a copy with the equipment instruction for use. For any further information or support customers should contact their local Philips representative or local Philips Healthcare office. Customers in North America and Canada should contact the Customer Care Solutions Center at 1-800-722-9377, option 5. For questions regarding this recall call 440-483-7000.
Quantity in commerce: 90 units
Distribution: Worldwide Distribution - USA including AL, AR, FL, GA, IO, IN, MI, NJ, NY, OH, OK, OR, PA, SC, TN, TX & WA and the countries of Australia, Canada, China, Czech Republic, France, Germany, India, Indonesia, Israel, Italy, Poland, Spain, Sweden, Switzerland & United Kingdom
Product codes and lots: M/N 881001, Serial Numbers: 30001, 30003, 30004, 30007, 30008, 30016, 30018, 30019, 35006, 79932, 79933, 79935, 79936, 79939, 79940, 80071, 80425, 80891, 80910, 80914, 80979, 80980, 80994, 81004, 81008, 81015, 81026-81028, 81031, 81035, 81063, 81065, 81079, 81081, 81085, 81089, 81119, 81127, 81129, 81130, 81132, 81133, 81147, 81150, 81157, 81161, 81163-81165, 81169, 81172, 82004, 82006-82009, 82011, 82015-82018, 82020, 82021, 82023-82030, 85006-85011, 85025-, 5027, 85029, 85041-85043, 85046, 85049, 85053, 85067 & 85068.

Product code KPS

K060937Class IIBrilliance VolumePhilips Medical Systems (Cleveland), Inc. / cleared 2006-06-05

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)