Recall Z-2000-2012— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2012-05-22, terminated 2013-03-28. It names 3 FDA 510(k) clearances: K060937, K033326, K012009. 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..
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-22
- Terminated
- 2013-03-28
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
3 on FDA's record- K060937 — BRILLIANCE VOLUME
- K033326 — PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
- K012009 — MX8000 IDT CT SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.