Reported Jul 18, 2012 · Terminated
Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that…
Philips Medical Systems (Cleveland) Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems (Cleveland) Inc · 595 Miner Road · Cleveland, OH · 44143-2131
Is this the product you have?
- Intellispace
- Portal software Product UsageIntellispace 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
- Lot codes and dates
- Model number881001
- serial numbers
80818850888117882006820388106382018799358115081013811738506879932799438091182019810278504985043820088111981089851088502685146809948102181182810178506781161811647993685103811478511085082811798103585046810318112981004 & 85104
- Amount recalled
- 44
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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