Data Foundry

Medical device recalls 2012

IntelliSpace Portal software and Extended Brillance Workspace… — Class II medical device recall Z-1987-2012

Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2012-07-18, distributed nationwide. The Intellispace Portal software and Extended Brillance Workspace software may have significantly different re

Recall numberZ-1987-2012
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Medical Systems (Cleveland) Inc, Cleveland, OH, United States
Recall initiated2012-05-23
Classified2012-07-11
Reported by FDA2012-07-18
Terminated2013-09-30
DistributedNationwide (US)
Countries outside the USAU, BE, CA, CH, DE, DK, ES, FI, FR, GB, ID, IL, IN, KR, RU, SE, ZA
Quantity38
Reason classessoftware
Serial numbers10102, 10155, 10173, 11169, 11994, 11995, 12050, 14170, 14171, 14691, 14834, 14955, 15016, 15018, 15658, 15677, 6483, 80818, 80911, 80979, 80994, 81003, 81004, 81013, 81017 and 9 more
Model numbers728260, 881001

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1987-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.