FDA Enforcement Class II Terminated

Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from compatible computers on a network.

Recall: Z-2000-2012 · Reported July 18, 2012

Enforcement

Recall Number
Z-2000-2012
Event ID
62128
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Philips Medical Systems (Cleveland) Inc
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
July 18, 2012
Initiation Date
May 22, 2012
Classification Date
July 11, 2012
Termination Date
March 28, 2013
Address
595 Miner Road, Cleveland, OH, 44143-2131, United States

Description

Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from compatible computers on a network.

Reason

In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using the editing mode "edit contour" tool, the measurements are not recalculated causing discrepancies with the lesion measurements.

Code Info

Model number: 881001; serial numbers: 80818, 85088, 81178, 82006, 82038, 81063, 82018, 79935, 81150, 81013, 81173, 85068, 79932, 79943, 80911, 82019, 81027, 85049, 85043, 82008, 81119, 81089, 85108, 85026, 85146, 80994, 81021, 81182, 81017, 85067, 81161, 81164, 79936, 85103, 81147, 85110, 85082, 81179, 81035, 85046, 81031, 81129, 81004 & 85104.

Distribution

Worldwide Distribution - US (nationwide) including the states of: AR, LA, MI, NC, NY, OH, OK and PA and the countries of: Australia, Canada, Denmark, France, Germany, Israel, Netherlands, Spain and Switzerland.

Quantity

44