Philips Medical Systems Recalls IntelliSpace Portal and Extended Brillance Workspace Software
Philips Medical Systems is recalling 38 units of IntelliSpace Portal and Extended Brillance Workspace software due to inconsistent diagnostic results when using specific time-based methods.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves inconsistent diagnostic software results without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Philips Medical Systems (Cleveland) Inc is recalling 38 units of IntelliSpace Portal software and Extended Brillance Workspace software. The IntelliSpace Portal is a multimodality thin-client applications server that delivers diagnostic viewing and clinical applications, while the Extended Brillance Workspace is intended for use as a diagnostic viewing and processing workstation.
The recall was initiated because the software may produce significantly different results in the colors and size of the affected area when customers use the "Time Sensitive" and "Time Insensitive" methods. This discrepancy could impact the consistency of diagnostic viewing.
The affected units were distributed worldwide, including in the United States (specifically Arizona, Oregon, Pennsylvania, and Texas) and in Australia, Belgium, Canada, Denmark, Finland, France, Germany, India, Indonesia, Israel, Russia, South Africa, South Korea, Spain, Sweden, Switzerland, and the United Kingdom. The recall involves specific model numbers 881001 and 728260 with listed serial numbers. Users should contact Philips Medical Systems for further instructions on resolving the software discrepancy.
The recalled product
- Product
- IntelliSpace Portal software and Extended Brillance Workspace software Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. The Philips Extended Brillance Workspace is intende
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Category
- Medical Device — Software
- Affected units
- 38
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: 85104
- 80818
- 85088
- 82038
- 81013
- 80911
- 82017
- 80994
- 81021
- 81017
- 81065
- 81161
- 81164
- 81130
- 81004
- 81003 & 80979. Model number: 728260
- serial numbers: 10102
- 6483
- 14691
Distribution
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