Z-1987-2012Class II

IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality...

Name: Z-1987-2012 IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality...
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 and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers... on 2012-05-23. FDA classified it as Class II and gives the reason as "The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time...". 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-1987-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-23
Posted: 2012-07-11
Terminated: 2013-09-30
Recalling firm: Philips North America LLC
Product: IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The Intellispace Portal software and Extended Brillance Workspace software may have significantly different results in the colors and size of the affected area when the customer uses the "Time Sensitive" and "Time Insensitive" methods.
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent a Urgent Medical Device Correction letter dated May 31, 2012, to all affected customers. The letter was sent via certified mail to each customer. The letter identified the product the problem and the action needed 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. For any further information or support, customers can contact their local Philips representative or local Philips Healthcare office at (1-800-722-9377 Option 5 : Entersite ID or follow the prompts). Additionally, a Field Service Engineer will contact each site to schedule time to implement the Field Change Order. The user was informed that a field service representative will visit the facility to install the new software. Philips apologizes for any inconveniences caused by this problem.
Quantity in commerce: 38
Distribution: Worldwide Distribution -- Nationwide Distribution including the states of AZ, OR, PA and TX and the countries of Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, and United Kingdom.
Product codes and lots: Model number: 881001; serial numbers: 85104, 80818, 85088, 82038, 81013, 80911, 82017, 80994, 81021, 81017, 81065, 81161, 81164, 81130, 81004, 81003 & 80979. Model number: 728260; serial numbers: 10102, 6483, 14691, 10155, 12050, 11169, 15016, 15677, 15658, 14834, 14955, 10173, 15018, 14171, 14170, 11994 & 11995.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1987-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1987-2012	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)