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Recall Observatory FDA recall evidence

Device 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.

Z-1987-2012

May 23, 2012

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 62005
Status
Terminated
Classification
Class II
Quantity
38
Official record key
device-enforcement:Z-1987-2012

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software and Extended Brillance Workspace software may have significantly different results in