RecallRadar

FDA Device recall Z-2000-2012

Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagn…

On 2012-07-18 the FDA classified a Class II recall of Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagn… by Philips Medical Systems Cleveland, citing 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 causin….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2000-2012
ClassificationClass II
Statusterminated
Initiated2012-05-22
Published2012-07-18
Last updated2026-09-13 11:53 UTC
CompanyPhilips Medical Systems Cleveland
DistributionUS

Product

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.

Identifiers

code_info
Model number: 881001; serial numbers: 80818, 85088, 81178, 82006, 82038, 81063, 82018, 79935, 81150, 81013, 81173, 8506…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2000-2012%22

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