FDAFDA · Food and drugs·Recall number Z-1987-2012
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.
Published July 18, 2012 · Recall initiated: May 23, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- 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.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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