Philips Intellispace Portal software recalled for tumor measurement errors
Philips Medical Systems is recalling Intellispace Portal software because tumor measurements are not recalculated when lesion contours are edited.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that leads to incorrect clinical measurements (discrepancies in lesion measurements), which poses a risk of harm to patient care, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 44 units of Intellispace Portal software, model number 881001. This software is a multimodality thin-client applications server that delivers diagnostic viewing and clinical applications to the enterprise, allowing multiple users to remotely access the system from compatible computers on a network.
The recall is due to a defect in the Multi-Modality Tumor Tracking application. When users change the contours of a lesion using the "edit contour" tool, the measurements are not recalculated. This causes discrepancies with the lesion measurements.
The affected units were distributed worldwide, including in the United States (specifically AR, LA, MI, NC, NY, OH, OK, and PA) and in Australia, Canada, Denmark, France, Germany, Israel, Netherlands, Spain, and Switzerland. Specific serial numbers for the affected units are listed in the agency's recall record. Users should contact Philips Medical Systems for instructions on how to resolve the issue.
The recalled product
- 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
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Hazard
- Affected units
- 44
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model number: 881001
- serial numbers: 80818
- 85088
- 81178
- 82006
- 82038
- 81063
- 82018
- 79935
- 81150
- 81013
- 81173
- 85068
- 79932
- 79943
- 80911
- 82019
- 81027
- 85049
- 85043
Distribution
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